RE: Where is the money in bioterrorism?

[Guest guest]

Dr. Nass,

Thanks for sending that link. I'm not sure if you remember me, but we spoke

about a month ago-I'm a reporter for the American Prospect magazine in

Washington working on a story about bioterror vaccine procurement. I should

let you know that I have filed a Freedom of Information Act request on a

handful of people involved in the military vaccine programs and am trying to

see (or uncover) their financial links to the pharmaceutical industry.

Also, I attended the Senate Subcommittee hearing last week and saw your

submitted testimony. I think you made a very persuasive argument and I plan

on quoting that in a forthcoming article on Bioshield II. Sadly, I

misplaced your written testimony in the last week and wanted to know if you

might be able to send me a copy.

Many thanks,

Mark

Mark Leon Goldberg

Writing Fellow

The American Prospect

2000 L Steet NW Suite 717

Washington, DC 20036

P: (202) 776-0730 EXT 120

F: (202) 776 0740

C: (202) 557 0795

_____

From: Meryl Nass [mailto:mnass@...]

Sent: Tuesday, February 15, 2005 9:45 AM

Subject: Where is the money in bioterrorism?

http://www.forbes.com/personalfinance/strategies/2005/02/14/

cz_sg_0214soapbox_inl.html

Meryl Nass, MD

Mount Desert Island Hospital

Bar Harbor, Maine 04609

207 288-5081 ext. 220

Our Anthrax information web site: http://www.dallasnw.quik.com/cyberella/

/files/VAERS.pdf

DESTROY QUARANTINED VACCINE:

http://www.PetitionOnline.com/mod_perl/signed.cgi?robi2662

<http://www.PetitionOnline.com/mod_perl/signed.cgi?robi2662 & amp;amp;amp;1>

& amp;amp;amp;amp;1

PETITION TO OVERTURN/REPEAL FERES DOCTRINE

http://www.petitiononline.com/fd1950/petition.html

To visit Dr. Meryl Nass's web site, go to: http://www.anthraxvaccine.org

Also visit: Anthrax Vaccine Benefit vs Risk: http://www.avip2001.net AND

http://www.MajorBates.com/

Anthrax Vaccine Network http://www.ngwrc.org/anthrax/default.asp

Military Vaccine Education Center link, http://www.milvacs.org

Sgt. Larson's story:

http://www.ngwrc.org/anthrax/heroes/sandralarson.htm

http://www.avip2001.net/CongressionalTestimony.htm

Tom Heemstra's new book -

http://www.anthraxadeadlyshotinthedark.com/index.html

Contact list owner: Gretchen at: anna_nim@...

[Guest guest]

Hello Mark & Dr. Nass,

The following links will might help in some ways....The homepage of the Homeland

Security link mentioned in the first 5 links may have an article on the stock

ownership of BIOPORT.

My buddy Ron can help you find stuff over there. His wife is a doctor and

has written articles on this topic as well.

Respectfully,

W. Trefts aka RAINBOWRISING @ www.gulfwarvets.com bulletin board.

Disabled USAF Veteran RAF Alconbury ( 1989-1991 )

Rainbow Rising

February 16, 2005

Dear Friends and Fellow Veterans,

THIS DOCUMENT IS A NEW ACCUMULATION OF WEB LINKS ABOUT ANTHRAX VACCINE AND

ENVIRONMENTAL HAZARDS OF THE FIRST GULF WAR.

PETITION TO STOP HUMAN TESTING ON SOLDIERS http://www.petitiononline.com/fd1950/

Dr. Pamela Asa’s Response To Critics

http://www.avip2001.net/OfficialDocuments_files/DrAsa.htm

Homeland Security Policy Group

http://search./search?p=Dr.+Pamela+Asa & btn=Search & ei=UTF-8 & fr=sbc-web & b\

=21

VACCINE A HOMEPAGE - A BOOK BY CNN SPECIAL REPORTER GARY MATSUMOTO

http://www.vaccine-a.com/

Testimony by Ross Perot on Govt. Reform

http://www.hspig.org/ipw-web/bulletin/bb/viewtopic.php?t=2102 & highlight=ross+per\

ot

Autoimmune Technologies ( Dr. Pamela Asa, Garry. ) Tulane University

SQUALENE ANTIBODY TESTING FOR GULF WAR ILLNESS http://www.autoimmune.com/

Female Sgt. Dead From Anthrax Vaccine

http://www.gulfwarvets.com/dead3.htm

COLO. WOMAN WAGING WAR ON ANTHRAX VACCINE

http://www.denverpost.com/Stories/0,1413,36~53~2535720,00.html

Expert : Anthrax Vaccines Not Proven

http://www.gulfwarvets.com/anthrax11.htm

Medical examiner links death to anthrax vaccine BioPort officials shocked by

word

Of employees autopsy :

http://www.gulfwarvets.com/anthrax11.htm

ARE VACCINES CAUSING MORE ILLNESS THAN THEY ARE CURING?

http://www.gulfwarvets.com/vexing.htm

ADDITIVE FOUND IN ANTHRAX VACCINES

http://www.gulfwarvets.com/additive.htm

SHAY’S REPORT FROM 2000

http://www.gulfwarvets.com/shays.htm

WALTER REED SQUALENE STUDY :

http://deploymentlink.osd.mil/deploymed/projects/DoD100.shtml

SQUALENE CAN PRODUCE ARTHRITIS IN RATS

http://www.nccn.net/~wwithin/squalene.pdf

Lot Numbers and Locations Where Squalene Laced Anthrax Vaccine Was Given ( From

Matsumoto’s book site )

http://forums.perseusbooksgroup.com/phpBB2/viewtopic.php?t=59 & start=90 & sid=7ea69\

4230306feeb96914c695ffbe753

Health Impact Study of Gulf War Illness

http://www.cdc.gov/nceh/publications/gulfwar/report.pdf

MOD website referring to Gulf War Illnesses:

http://www.mod.uk/issues/gulfwar/index.html

Statement by the Ministry of Defence:

http://www.mod.uk/issues/gulfwar/info/medical/bwa.htm

King's Centre for Military Health Research:

http://www.kcl.ac.uk/kcmhr

Problems With Vaccines In General

http://www.anthraxvaccine.org/vaccinearticles.htm

Induction and Detection of Antibodies to Squalene

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_uids=1\

1042279 & dopt=Abstract

Statement of Congressman Jack Metcalf ( 2000 )

http://www.autoimmune.com/SqualeneInVaccine.html

American Gulf War Veterans Association www.gulfwarvets.com/

National Gulf War Resource Center: www.ngwrc.org/

Desert Storm.Com: http://www.desert-storm.com/

New Hampshire Gulf War Syndrome Association: www.nhgws.org/index.htm

Lots of documents http://Odssa-lodssa/

The Reigle Report: What veterans have been exposed to and a look at the U.S.

government’s involvement: www.gulfwarvets.com/arison/banking.htm

MILVACS: http://www.milvacs.org/Sick/Suggestions.cfm

You may view the archives of at:

http://onelist.com/archive/ Below is a 'must read' very informative

and professional http://mars.healthnet.org/MGS/V5N2Anthrax.html

Man Claims Anthrax Vaccine Almost Killed Him : THE STORY OF BRAD PRIESTER

http://www.firstcoastnews.com/news/local/news-article.aspx?storyid=27100

Man Claims Anthrax Vaccine Almost Killed Him

By Tiani

First Coast News

HOW THE ANTHRAX VACCINE AFFECTED Sr. Airman J. Colosimo

http://members.tripod.com/tomcolosimo/id27.htm

********************************************************************************\

**********************************************

VIDEO STORY LINKS

Air Force Sgt. Claims Anthrax Vaccine Nearly Killed Him ( video link )

http://ww2.abc11tv.com/global/video/popup/pop_index.asp?LaunchPageAdTag=News & Cli\

pID1=351994 & h1=VIDEO%3A%20Eyewitness%20News%20Investigates%3A%20Air%20Force%20Se\

rgeant%20Says%20Anthrax%20Shot%20Nearly%20Killed%20Him & vt1=v & at1=News%20-%20Spec\

ial%20Coverage & d1=298933 & activePane=playlist & playerVersion=9 & rnd=8705526

CBS NEWS LINKS PAGE :

http://search.atomz.com/search/?sp-q=anthrax+vaccine+video & sp-k= & sp-a=sp1001c63c\

& sp-p=all & sp-f=ISO-8859-1 & sp-s=doc_date

ALSO CLICK ON THE VIDEO TRAILER BEYOND TREASON @

www.gulfwarvets.com

Necessary Vaccine or Betrayal : Article From Winds of

www.windsofchange.net/archives/006063.php

December 23, 2004

Necessary Anthrax Vaccinations, or Betrayal?

by Joe Katzman at December 23, 2004 08:06 AM

Yesterday's story about Den Beste's degenerative disease, and the methods

he used to keep blogging, was unutterably sad (great comment, T.J. Madison).

It's past time I addressed another story - a chilling story - about degenerative

disease. Kudos to Ron of HSPIG for bringing it to my attention.

What if " Gulf War Syndrome " is real (contrary view here), and it and other

degenerative diseases showing up in U.S. veterans were the result of a " second

generation " U.S. government vaccine against anthrax administered to troops

without informed consent in 1991?

The U.S. military is about to restart that vaccine program (see also this

oficial .MIL site), despite that experience and despite a long history of

medical understanding that a key vaccine component called squalene was a

dangerous catalyst for degenerative auto-immune diseases.

This is a story you need to read.

Award-winning journalist Matsumoto has done a lot of research on this

topic, and written a book whose conclusions are summarized here. Some excerpts

follow.

From the book site:

" For the past 17 years, the Army has been working on a new anthrax vaccine that

contains no anthrax, and is made with an ingredient that it does not want to

name. That ingredient is called squalene. Squalene is an oil. Without it, the

new vaccine will not work any better than the old one. In fact, for all intents

and purposes, without squalene the new vaccine is the old one. What makes

squalene so important is its proven ability to stimulate a strong response from

the immune system. That is something the main ingredient of the new vaccine, the

now ultra-purified protein secreted by the anthrax microbe—recombinant

protective antigen—cannot do by itself. It is too weak.

Immunologists have a special name for substances used to boost feeble vaccines.

They are called adjuvants. Adjuvants are arguably the most extensively

researched pharmaceutical product in the last quarter century that you never

heard of. I have used the word adjuvant three times in this paragraph so far and

that is probably three times more than you have ever seen it in print before.

This is partly because the most effective adjuvants, those formulated with oils,

are too dangerous for human use. That is squalene's other proven ability,

causing incurable disease.... As early as the 1930s, these oil additives were

notorious for inducing illness. By the 1950s, scientists knew these illnesses

were specifically autoimmune. Today that is their chief use in research—inducing

disease instead of preventing it. Scientists studying autoimmune disease cannot

wait around for its spontaneous appearance in a lab animal; they inject it with

Freund's Complete Adjuvant to reproduce autoimmunity on

demand. "

Auto-immunity? Den Beste could give the full explanation, but here's a

short one:

" Autoimmune diseases are chronic and progressively debilitating ailments; some,

like multiple sclerosis and lupus, can be fatal. They occur when the immune

system loses its ability to distinguish what is " self " from what is foreign.

Under normal circumstances, your immune system ignores the constituents of your

own body; immunologists call this " tolerance. " But if tolerance is broken, the

immune system turns relentlessly self-destructive, attacking the body it is

supposed to defend. "

A vaccine using such substances? " How the hell could this happen, " you may ask.

A combination of reasons, it seems - some of which are legitimate and

potentially defensible decisions, some that are less so, and some that don't

strike me as defensible in any context.

Let's start with the attractive abilities of adjuvants:

" Despite their dangers, oil adjuvants have come to exert an irresistible, almost

magical allure on researchers. If they could truly stimulate the immune system

safely, oil additives could help defend mankind from diseases like malaria and

HIV. For germs such as these, no one dared make a classic vaccine - the kind

made from the germ itself - for fear of accidentally infecting someone with an

incurable, if not fatal infection. By splicing off just little bit of such a

germ - not enough to make anyone sick - and combining that shard with an

adjuvant, scientists hoped to protect people from lethal microbes. If they could

do it for HIV, they reasoned, they could do it for any germ in creation. This

siren song was so powerful that it did more than induce researchers to indulge

in cynical risk/benefit calculations; in some cases, it made them forget the

risks altogether. "

Over to 1991 on the eve of Gulf War 1, as the Pentagon weighed the relative

risks:

" At the start of Gulf War One, our military leaders believed anthrax attacks

against the troops on the ground were a real and potentially devastating

possibility. When they looked in their pantry of vaccines, they found only a few

doses of an anthrax vaccine that takes six shots over a long period to instill

immunity to attack. Further, the pantry had no battlefield detection devices to

even know if soldiers had been exposed. Casualties could be very high, the

deaths would be ghastly, and press cameras were always at the ready. The

military leadership ordered subordinates to find a solution.

Coincidentally, some military and civilian researchers had been working on a

new, second generation vaccine for anthrax. One or two shots would do it.

Immunity developed quickly and strongly. Soldiers would live to fight another

day. It was safer to manufacture since whole anthrax particles were not used,

only bits and pieces.... "

It's not such an obvious decision when looked at in that light, but some aspects

including the lack of informed consent are absolutely inexcusable. There was

also old research not recalled from a similar situation:

" By all accounts, the great Spanish Flu pandemic of 1918 wasn't really Spanish

at all. It was American. In fact, it was an Army flu. The first victim, the

" index patient, " was an Army private named Albert Gitchell who worked as a cook

at the Army's Camp Funston on the vast Fort Riley military reservation in

Kansas. It is believed that U.S. troops heading to Europe brought this flu with

them. Before it was over, more than 20 MILLION people had died of influenza

around the world—the deadliest natural disaster in world history. Army

scientists wanted to prevent another global killer from emerging from an Army

post where new recruits might become an unintended hatchery for some vicious new

flu strain that once again could wipe out millions of people. Trying out a new

oil additive on troops seemed like a relatively modest risk in comparison to the

benefits of a better flu vaccine.

.....The Armed Forces Epidemiological Board (AFEB), which would be sponsor a

large number of the experiments conducted on military personnel, would later

recommend the injecting an experimental flu vaccine containing oil into every

man and woman in the U.S. military without their informed consent. The risk of

an outbreak of killer flu seemed too great to do otherwise. To run this

experiment, the Army would contract none other than Jonas Salk..... "

Nor was this the only instance.

" Long before the last study was completed, AFEB proposed the adoption of an

experimental flu vaccine with oil for everyone in the military. In 1963 and

1964, AFEB recommended injecting every man and woman in the armed forces with

the new vaccine. The board also recommended that Department of Defense also

commence studies with oil added to tetanus and diphtheria toxoids, and polio

vaccines....

Here is what they were not telling anybody. By 1964, the year when everyone in

the military was supposed to get immunized with an oil-boosted influenza

vaccine, the Army already knew the risks this vaccine presented for a very

specific type of illness..... autoimmune diseases.

The final study on the Fort Dix [JK: 1951] troopers had data that none of the

previous ones had: autopsy results..... a " significant excess of deaths " in

soldiers given the oil-boosted vaccine, which the investigators related to

" ill-defined vascular lesions of the central nervous system. " They attributed

this fact to the greater number of autopsies available for the soldiers given

the oil-boosted vaccine. But there were hints of a problem with autoimmunity.

Ten percent of the soldiers studied, who were injected with the oil-boosted

vaccine, developed a " collagen disease, " which is a term doctors used to use

interchangeably with autoimmune disease. Still, the number of patients in this

study was too low to extrapolate any reliable conclusions from the data. That

did not prevent government and military doctors from doing just that. They

concluded that the oily flu vaccine was safe. Nevertheless, what the government

then did not do was telling. The FDA never licensed the vaccine, or

the oil adjuvant, for human use. "

Fast forward to 1991. Over to Marilyn 's summary:

" Someone had forgotten or ignored solid research showing squalene was very bad

news for the lab animals injected with it. And now the same symptoms were

showing up in veterans. And only veterans who got the shot got sick, whether or

not they were exposed to ground conditions in Iraq. Some sick vets had never

even left the U.S. It was the vaccine that was the common denominator.

In the meantime, the government and the manufacturer of squalene were moving

forward with plans to develop other vaccines using the new wonder ingredient... "

One of the first strong indicators that something was amiss was data published

in the February 2000 and August 2002 issues of Experimental and Molecular

Pathology, which strongly suggested that Gulf War Syndrome is caused by a

vaccine contaminated with squalene. Matsumoto has picked up the ball, and

brought together information from many sources to move this story forward.

This is a story of corners cut and forced decisions amidst the pressures of war,

of crippling side effects for some U.S. troops, and of recent moves to restart

this vaccination program that are hard to see as anything but recklessness

bordering on betrayal if Matsumoto's charges hold up.

Note my use of the word " if " . There may well have been exaggerated stories in

the past along similar lines, most notably in relation to Agent Orange. The

reality of Gulf War Syndrome itself is open to debate among reasonable people.

Nevertheless, there's a lot of research here whose conclusions seem to fit, and

Matsumoto has said that he welcomes close scrutiny.

I say, bring it on. I don't have the necessary level of medical expertise to

full evaluate this story... but I'd like to hear from people who do.

Our troops deserve the truth here - and the unalterable right of informed

consent. They are free citizens serving by choice, not guinea pigs. If Matsumoto

is right, that's exactly how they're being treated. And that would be truly

inexcusable.

UPDATE: Phil (author of Intel Dump) emails me to note that Jon Cohen

penned a very critical review of Mastumoto's book in Slate last month. It's an

excellent summation of the other side of the argument.

GOVERNMENT TRANSCRIPTS ADMITTING USE OF SQUALENE BEFORE & AFTER 1ST GULF WAR

________________________________________________________________________________\

______________________________________

Gulf War Illnesses: Questions About the Presence of Squalene Antibodies

in Veterans Can Be Resolved (Letter Report, 03/29/99, GAO/NSIAD-99-5).

Pursuant to a congressional request, GAO investigated the reports that

the blood samples of some ill Gulf War-era veterans contained antibodies

for squalene, a component of adjuvant formulations used in some

experimental vaccines but not in any licensed vaccines, focusing on

whether: (1) the Department of Defense (DOD) or the National Institutes

of Health (NIH) performed or sponsored research using squalene; (2) DOD

considered using adjuvant formulations in vaccines administered to Gulf

War-era veterans; and (3) any research has detected the presence of

squalene in ill Gulf War-era veterans.

GAO noted that: (1) prior to and following the Gulf War, DOD and NIH

used adjuvant formulations of squalene to perform research on the

development of more effective vaccines; (2) DOD officials stated they

considered, but decided against, using vaccines with experimental

adjuvant formulations during the Gulf War; (3) according to independent

researchers, as part of their treatment of sick Gulf War-era veterans,

they developed and administered a test, referred to as an assay, that

detected antibodies to squalene in the blood of sick Gulf War-era

veterans; (4) the researchers stated this assay is similar to a standard

assay used in other types of research; (5) as of March 1999, the

research has been subjected to peer review, but had not been published;

(6) this process is often lengthy, sometimes taking a year or more; (7)

according to DOD officials, DOD could develop such an assay

inexpensively and test it on a sample of sick Gulf War-era veterans; (8)

however, DOD plans to wait until the research is published before

deciding whether to conduct testing; and (9) given the researchers'

assessment, DOD's comments about the feasibility of developing an assay

and that veterans have been waiting for the past 7 years for answers on

the nature and origin of their illnesses, DOD has the opportunity to

expand on the research already performed.

--------------------------- Indexing Terms -----------------------------

REPORTNUM: NSIAD-99-5

TITLE: Gulf War Illnesses: Questions About the Presence of

Squalene Antibodies in Veterans Can Be Resolved

DATE: 03/29/99

SUBJECT: Veterans

Research reports

Medical research

Disease detection or diagnosis

Testing

IDENTIFIER: Persian Gulf War

NS99005.book GAO United States General Accounting Office

Report to the Honorable Jack Metcalf House of Representatives

March 1999 GULF WAR ILLNESSES

Questions About the Presence of Squalene Antibodies in Veterans

Can Be Resolved

GAO/NSIAD-99-5

GAO/NSIAD-99-5

United States General Accounting Office Washington, D. C. 20548

Lett er

Page 1 GAO/NSIAD-99-5 Gulf War Illnesses

GAO

National Security and International Affairs Division Lett er

B-278779 March 29, 1999 The Honorable Jack Metcalf House of

Representatives

Dear Mr. Metcalf: You expressed concern about reports that the

blood samples of some ill Gulf War- era veterans contained

antibodies for squalene 1 a component of adjuvant formulations

used in some experimental vaccines but not in any licensed

vaccines. 2 As requested, we identified whether (1) the Department

of Defense (DOD) or the National Institutes of Health (NIH)

performed or sponsored research using squalene, (2) DOD considered

using adjuvant formulations in vaccines administered to Gulf War-

era veterans, and (3) any research has detected the presence of

squalene in ill Gulf War- era veterans.

Results in Brief Prior to and following the Gulf War, DOD and NIH

used adjuvant formulations of squalene to perform research on the

development of more effective vaccines. DOD officials stated they

considered, but decided against, using vaccines with experimental

adjuvant formulations during the Gulf War. According to

independent researchers, as part of their treatment of sick Gulf

War- era veterans, they developed and administered a test,

referred to as an assay, that detected antibodies to squalene in

the blood of sick Gulf War- era veterans. The researchers stated

this assay is similar to a standard assay used in other types of

research. As of March 1999, the research had been subjected to

peer review, but had not been published. This process is often

lengthy, sometimes taking a year or more. According to DOD

officials, DOD could develop such an assay inexpensively and test

it on a sample of sick Gulf War- era veterans. However, DOD plans

to wait until the research is published before deciding whether to

conduct testing. Given the researchers' assessment, DOD's comments

about the feasibility

of developing an assay and that veterans have been waiting for the

past 1 Squalene is found in shark liver oil, some vegetable oils,

and the human liver and can also be manufactured through chemical

engineering. Squalane is the hydrogenated form of squalene. When

we use the term squalene by itself, it refers to both squalane and

squalene. 2 An adjuvant is a substance incorporated in a vaccine

to accelerate, enhance, or prolong a specific immune response. An

antigen is a substance that stimulates production of an antibody.

Neither squalane or squalene is a complete adjuvant by itself.

Both serve as vehicles in which adjuvant formulations and vaccine

antigens can be mixed and delivered.

B-278779 Page 2 GAO/NSIAD-99-5 Gulf War Illnesses

7 years for answers on the nature and origin of their illnesses,

DOD has the opportunity now to expand on the research already

performed.

Background Many of the approximately 700,000 veterans of the Gulf

War have reported health problems. Some fear that their illnesses

might be due to exposure to chemicals, pesticides, and other

agents used during the war, including

vaccines administered to protect them against biological warfare

agents. Questions about vaccine adjuvant formulations were raised

to DOD in June 1994. At that time, an immunologist from the

private sector notified the

Defense Science Board that some symptoms being reported by Gulf

War- era veterans were very similar to those of her patients with

autoimmune diseases. These patients had a range of symptoms

affecting more than one of the body systems and the immunologist

believed they were associated with exposure to vaccine adjuvant

formulations. In October 1995, DOD, before a meeting of the

Presidential Advisory Commission on Gulf War illnesses, dismissed

this hypothesis on the grounds that it had administered only

vaccines with aluminum salts as adjuvants. In November 1996 and

again in 1997, the immunologist notified DOD, based on independent

research, that she had found antibodies to squalene in the blood

of a few sick veterans who had served in the military during the

Gulf War. However, DOD has not responded to these findings.

According to the researcher, she continues to be willing to

discuss the

research with DOD. To date, aluminum hydroxide is the only

adjuvant used in vaccines licensed by the Food and Drug

Administration (FDA) in the United States. While widely considered

to be safe, this adjuvant provides only a limited boost in the

immune response, and researchers have long emphasized the critical

need for new, more effective adjuvant formulations. According to

the National Institute of Allergy and Infectious Diseases (NIAID),

the branch of NIH that sponsors most of its vaccine- related

research, a new generation of novel adjuvant formulations are

being developed. These formulations are

intended to enhance and optimize immune responses to vaccines;

enable easier delivery of antigens, and reduce the amount of

antigen and the number of immunizations required for protective

immunization. Squalene is a common component of these new

formulations. As with all drugs and biological products, the

absolute safety of adjuvant formulations can never

B-278779 Page 3 GAO/NSIAD-99-5 Gulf War Illnesses

be guaranteed. 3 Safety concerns have been cited 4 regarding the

use of novel adjuvant formulations in vaccines, including

squalene, and the associated adverse reactions. 5 It has also been

suggested that the safety of vaccines containing these

formulations must be evaluated in conservative ways. 6

DOD and NIH Performed and Sponsored Research With Squalene

DOD and NIAID officials reported that, to help develop more

effective vaccines, they conducted research using adjuvant

formulations with squalene. In all, they performed or sponsored 28

clinical trials on vaccines using adjuvant formulations with

squalene, and 1,749 human subjects participated in these trials.

Prior to the Gulf War, both organizations were devising ways to

induce a rapid response to several vaccines using adjuvant

formulations with squalene. DOD officials stated that they

considered, but

decided against using vaccines with adjuvant formulations

including those with squalene to protect Gulf War troops.

DOD Research Between 1988 and 1998, DOD sponsored 101 clinical

trials on vaccines as part of a process required by FDA for

licensing investigational new drugs (IND). At least 21 of these

trials involved vaccines with adjuvant formulations, and 5 of

these 21 involved adjuvant formulations containing

squalene. These formulations were available from U. S. firms. 7

(See app. I for specific information on these firms and the

development of adjuvant formulations with squalene.) In the five

trials involving squalene, 572 human subjects volunteered and

participated. Of the five trials, two began

before the Gulf War. DOD officials could not confirm whether any

of the 3 J. L. Bussiere et al., " Preclinical Safety Assessment

Considerations in Vaccine Development " In , M. F. and

Newman, M. J. (Eds.) (1995). Vaccine Design: The Subunit and

Adjuvant Approach (New York: Plenum Press), pp. 61- 75. 4

Goldenthal, K. L. et al., " Safety Evaluation of Vaccine Adjuvants:

National ative Vaccine Development Meeting Working Group, "

AIDS Research and Human Retroviruses, vol. 9 (1993), pp. S47- S51.

Lorentzen, J. C. Identification of Arthritogenic Adjuvants of Self

and Foreign Origin. Scandinavian Journal of Immunology, vol. 49

(1999), pp. 45- 50. 5 Adverse reactions are local or systemic.

Local reactions include pain and swelling at the injection site.

Systemic reactions include fevers and toxicity of organs and

systems. 6 M. F. and M. J. Newman, Vaccine Design: The

Subunit and Adjuvant Approach (New York: Plenum Press, 1995) 7

This information was derived from DOD data submitted to FDA and

may not include cooperative research efforts with others.

B-278779 Page 4 GAO/NSIAD-99-5 Gulf War Illnesses

volunteers in studies that DOD sponsored had deployed to the Gulf

War. The five trials are described as follows: In April 1988,

DOD's first clinical trial of an experimental malaria vaccine with

an adjuvant containing squalene was approved, 8 but according to

DOD, doses were actually administered from June 1989 to January

1990. Five volunteers were given the vaccine. In August 1990,

another trial of the malaria vaccine was approved, using

the same adjuvant with squalene on 12 volunteers. 9 In 1994, DOD

began another study on a malaria vaccine containing an adjuvant

with squalene. 10 Both 110 experimental subjects and 11 control

subjects were given the adjuvant. An additional arm of the study,

using human subjects from Gambia, was withdrawn before any

vaccines were given because of concerns about the stability of the

product. In 1995, through a cooperative research and development

agreement, the Chiron Biocine Company and the Walter Army

Institute of Research began a clinical trial of a vaccine for

Human Immunodeficiency Virus (HIV) that contained an adjuvant with

squalene. 11 The vaccine containing squalene was given to 41

healthy volunteers in Thailand, and the adjuvant with squalene

without the rest of the vaccine was given as a placebo to 13

people in a control group.

In 1997, the Walter Army Institute of Research began to

cosponsor another study in Thailand on an HIV vaccine with an

adjuvant formulation containing squalene, which is ongoing. 12

This study will give both the experimental and control subjects

the adjuvant formulation with squalene. Three hundred and eighty

subjects have been recruited for this study; 3 are Americans and

the remaining are Thai citizens.

8 IND 2699. " Safety and Immunogenicity of a Plasmodium falciparum

Malaria Sporozoite Vaccine, R32NS1 81 With DETOX TM As An

Adjuvant. " 9 IND 3714. " The Protective Efficacy of a Plasmodium

falciparum Vaccine, R32NS1 81 and MPL/ CSW as an Adjuvant. " 10 IND

6043. " Plasmodium falciparum Circumsporozite Antigen Vaccine

(Recombinant, Yeast) with Alum, QS21, MPL and SB62 Adjuvant

Combinations. " 11 IND 4096. " A Phase I Trial of Biocine HIV SF2 gp

120/ MF59 Vaccine in Seronegative Thai Volunteers. "

12 IND 7172. " A Phase I/ II Double- blind, Placebo- controlled

study of the Chiron HIV Thai E gp 120/ MF59 Vaccine Administered

alone or Combined with the Chiron HIV SF2 gp120 Antigen in Healthy

HIV- Seronegative Thai Adults. "

B-278779 Page 5 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix II provides further details on these studies, and

appendix III provides a list of DOD research publications on those

trials involving human subjects.

In addition, DOD has conducted several experiments on animals,

using vaccines with adjuvant formulations containing squalene, for

a wide range of diseases, including anthrax, toxic shock, and

malaria. The anthrax vaccine experiments with adjuvant

formulations containing squalene began in 1987, and some of the

results have been presented at conferences and published in

several medical journals. (See app. IV for a list of some of DOD's

animal research on adjuvant formulations with squalene). DOD's

animal studies are of interest for two reasons. First, because

tests on

animals are generally performed before human trials, they

represent the first step of vaccine research and provide a more

complete picture about the state of research on adjuvant

formulations with squalene before the

Gulf War. Second, since vaccines against biological warfare cannot

be tested for efficacy in humans, animal research is considered

essential by researchers.

NIH's Research on Vaccines With Adjuvant Formulations Containing

Squalene

NIAID officials stated they have sponsored vaccine trials on

various adjuvant formulations, including several with squalene.

NIAID's research on vaccines and adjuvant formulations has

increased substantially over the last 10 years. The total number

of active vaccine projects more than doubled, from 212 in 1987 to

539 in 1997. Research involving adjuvant formulations expanded at

an even faster pace, from 13 studies in 1987 to

59 active projects in 1997. NIAID's clinical research on novel

adjuvant formulations involving human subjects began in 1988.

NIAID- sponsored basic/ preclinical studies on adjuvant

formulations with squalene began in 1987, and clinical trials

began at the same time as Operation Desert Storm, in January 1991.

Since then, NIAID has sponsored at least 23 trials of vaccines

involving adjuvant formulations with squalene, with 1,177 human

volunteers. 13 Nineteen of the 23 trials involved an HIV vaccine

tested on a total of 935 volunteers; the 4 remaining trials

involved a vaccine for herpes with 242 subjects. (See app. V for a

list of the 23 studies.

13 Establishing the exact number of studies is difficult because

NIAID's databases often do not specify the adjuvants used in both

preclinical and clinical studies. Also, 2 years after the studies

are completed, the records are routinely destroyed and only an

index is maintained.

B-278779 Page 6 GAO/NSIAD-99-5 Gulf War Illnesses

DOD Officials Report They Considered, but Decided Against, Using

Vaccines With Novel Adjuvent Formulations, Including

Squalene In August 1990, DOD established various committees to

address its concerns about the threat of Iraqi biological warfare

agents and the

insufficient supply of vaccines to immunize all troops against

these agents. These committees identified several problems. They

determined that DOD had neither a sufficient quantity of vaccine

nor the manufacturing capacity to protect the force. It also did

not have sufficient time to administer the

required six anthrax shots over 18 months and faced formidable

logistical problems in giving multiple shots to troops in various

locations in the Persian Gulf region. According to DOD officials,

the use of novel adjuvant formulations for the anthrax vaccine was

rejected because any alteration in the licensed vaccine would

require relicensure, and DOD would not receive FDA approval in

time. Other alternatives were pursued. DOD requested help from

commercial U. S. and foreign vaccine manufacturers; NIH, through

its

National Cancer Institute facility at Fort Detrick, land; and

additional military production facilities at Fort Detrick and

Porton Down, United Kingdom. According to the commercial

manufacturers, they turned DOD down because developing a safe and

effective vaccine takes sustained investment and planning and DOD

had not previously been willing to invest the money and time. DOD

began immunizing troops in Janaury 1991. However, it should be

noted that even if the manufacturing capacity had

been increased, DOD never had the 18- month time span needed to

fully immunize the troops in the Gulf War because of the war's

short duration.

Although DOD awarded contracts to the National Cancer Institute to

produce additional anthrax vaccine and began planning production

of additional botulinum toxoid vaccine at the U. S. Army Medical

Research Institute of Infectious Diseases, also located at Fort

Detrick, the two institutes were unable to begin production before

the war. DOD officials said that botulinum toxoid vaccine was

acquired from Porton Down, United Kingdom, but was not used.

Consequently, according to DOD, the only vaccines against

biological warfare agents anthrax and botulinum toxoid given

during the Gulf War were produced by the Michigan Department of

Public Health. It subsequently became an independent

agency, the Michigan Biologic Products Institute, and was recently

privatized as BioPort. Officials at BioPort said that they have

never used adjuvant formulations containing squalene.

We cannot say definitively whether or not Gulf War- era veterans

were given vaccines with adjuvant formulations containing squalene

for a number of reasons. Although DOD officials told us they did

not administer such

B-278779 Page 7 GAO/NSIAD-99-5 Gulf War Illnesses

vaccines, they stated they did not have documentation on the

process and results of decision- making related to the

administration of vaccines at the time of the Gulf War. Also, some

officials involved in the decisions were no longer employed with

DOD at the time of our review, and we were either unable to locate

them or they declined to be interviewed.

Independent Researchers State They Have Detected

Squalene Antibodies in Gulf War- Era Veterans

In examining the pathology of illnesses afflicting Gulf War- era

veterans, independent researchers examined whether antibodies to

squalene were present in patients who had and had not been

deployed to the Gulf War. Using an assay that they developed the

researchers stated that they

detected squalene antibodies in the blood of sick Gulf War- era

veterans. The immunologist who headed this study and laboratory

researchers at a major university medical center that were

involved in the study shared their methodology and findings with

us. The results of the research have been submitted to a medical

journal to be peer reviewed and published. As

of February 1999, there was no set date for publication. According

to the researchers, the antisqualene antibody assay that they

developed in their study is a variant of the common Western Blot

assay 14 and is similar in format to a test cited in a published

report on silicone antibodies. 15 Using the antisqualene antibody

assay, the independent researchers stated they found most veterans

with Gulf War illnesses in their research had the antibodies to

squalene, regardless of whether they were deployed or not.

Non veterans in the research that were known to have received

adjuvant formulations with squalene as volunteers in clinical

trials of experimental vaccines also had the antibodies to

squalene and had an array of symptoms similar to symptoms of the

Gulf War patients. On the other hand, those participants (in the

control groups) that were healthy with no autoimmune symptoms,

those non- Gulf War veterans with autoimmune diseases of

unknown origin, and those who had received other adjuvant

formulations were found not to have antibodies to squalene. The

independent researchers concluded that, while the reason for the

presence of the

14 The Western Blot assay applies a protein or polymer such as

squalene to test strips, which are then incubated with patient

serum. If the antibody of interest is present, test strips turn

bluish black. A darker color indicates a higher concentration of

antibodies.

15 S. A. Tenenbaum et al., " Use of anti- polymer antibody assay in

recipients of silicone breast implants, " The Lancet, vol. 349

(1997), pp. 449- 454. For correspondence concerning this study see

" Antipolymer antibodies, silicone breast implants, and

fibromyalgia, " The Lancet, vol. 349 (1997), pp. 1170-- 1173.

B-278779 Page 8 GAO/NSIAD-99-5 Gulf War Illnesses

squalene antibodies remains unclear, the presence of these

antibodies could potentially be a contributing factor to Gulf War

illnesses. DOD officials stated they could develop an assay, or

test, for detecting antibodies to squalene. According to these

officials, it would not be expensive to develop the assay and test

it on a sample of Gulf War- era veterans that are sick. However,

they believed that since DOD did not use adjuvants with squalene,

DOD does not need to develop such an assay or to screen the

veterans for the antibodies. Second, squalene is a substance that

occurs naturally in the human body, and they doubted that an assay

could be developed to differentiate antibodies to natural and

manufactured squalene. Third, they noted that squalene is also

found in numerous topical creams that some soldiers could have

used. Finally, DOD officials do not believe that funding squalene

antibodies in veterans would prove that the

antibodies caused Gulf War illnesses. Consequently, DOD intends to

wait until the independent researchers publish their research in a

peer- reviewed journal before deciding whether to conduct testing.

Conclusions and Recommendation

Time is critical for many Gulf War- era veterans who continue to

suffer from illnesses and have been waiting for the past 7 years

for an explanation about the nature of their illnesses. It is

therefore important that DOD takes advantage of any opportunity to

obtain and evaluate additional information on the veterans'

symptoms and potential contributing factors. Independent

researchers, using an assay that they state is similar to standard

research assays, have concluded that squalene antibodies are

present in sick Gulf War- era veterans that participated in their

research and are a potential contributing factor to these

veterans' illnesses. DOD officials stated that it is feasible to

develop and apply an assay to test for squalene antibodies. Yet

for various reasons, including its assertion that it did not use

adjuvant formulations with squalene, DOD plans to wait until the

researchers' research is published before considering whether to

conduct its own

testing. However, publication is usually a lengthy process and may

take more than a year. Given that Gulf War- era veterans have

already waited a significant amount of time for information on

their illnesses, we believe that DOD should act now to expand on

the research already conducted.

Although the origin of the antibodies may be important to assess,

the first step is to determine the extent to which they are

present in a larger group of sick Gulf War- era veterans. We

therefore recommend that the Secretary of Defense review the

independent research that researchers report has revealed the

presence of squalene antibodies in the blood of ill Gulf War- era

B-278779 Page 9 GAO/NSIAD-99-5 Gulf War Illnesses

veterans and conduct its own research designed to replicate or

dispute these results. Agency Comments In written comments on a

draft of our report, DOD disagreed with our recommendation to test

for antibodies for squalene in the blood of ill Gulf War- era

veterans. DOD stated there is no basis for believing veterans were

exposed to vaccines containing squalene. DOD further believes that

the proposed testing for the presence of squalene antibodies will

not appropriately address or assist in resolving the issue of

whether such antibodies may be a contributing cause to the

illnesses of Gulf War- era veterans. Specifically, DOD stated no

experimental vaccines with squalene had been used in U. S. troops

during the Gulf War and that the manufacturer of vaccines verified

it had never used adjuvant formulations containing

squalene. DOD noted that we concluded there was no evidence that

Gulf War- era veterans were given adjuvant formulations containing

squalene, and it therefore believes our proposal to test veterans

seems scientifically and fiscally irresponsible. DOD suggested

that our report be titled Gulf War Illnesses: Gulf War Veterans

Did Not Receive Vaccine Adjuvant

Formulations Containing Squalene. DOD further stated the assay

developed by independent researchers has not been validated

through peer review or publication in scientific literature and

that it is correctly adhering to widely accepted standards by

awaiting such validation before considering the use of the assay

in Gulf War illness studies. It also believed our recommendation

to test for squalene antibodies showed a lack of understanding of

scientific methods. In particular, DOD stated the presence of

antibodies would not establish an

association with adverse health outcomes and establishing an

association would require a statistically meaningful study of

randomly selected Gulf War veterans and non deployed veterans. DOD

noted that any

experimental design to test for this association must be evaluated

for scientific merit through independent peer review.

DOD misstated our finding on whether Gulf War- era veterans may

have received vaccine adjuvant formulations containing squalene.

We did not conclude that Gulf War era veterans were not given

adjuvant formulations containing squalene. Rather, we cannot say

definitively whether or not Gulf War- era veterans were given

these formulations. We have modified the report text to make this

point clear. Furthermore, it was not our

B-278779 Page 10 GAO/NSIAD-99-5 Gulf War Illnesses

intention to focus on how squalene antibodies may have been

introduced into the blood of the veterans. Rather, the focus

should be on the opportunity to resolve whether such antibodies

are present in the blood of ill Gulf War- era veterans, and if so,

whether or not they play a role in their illnesses. In this

respect, the results of the independent research suggesting that

antibodies to squalene are present in ill Gulf War- era veterans

participating in their research cannot be ignored.

We continue to believe that DOD should take this opportunity to

begin addressing and potentially resolving the question of whether

or not squalene antibodies may be contributing to the illnesses of

Gulf War- era

veterans. Specifically, DOD should conduct research designed to

replicate or dispute the independent research results that

revealed the presence of squalene antibodies in the blood of ill

Gulf War- era veterans. We modified our recommendation to clarify

this position. If DOD's research affirms the

presence of these antibodies, additional research should be

conducted that is designed to assess the significance of that

finding. This would simply be a first step in the research process

and would not finally resolve the issue of whether or not squalene

antibodies are a marker for, contribute to, or cause the

illnesses. Follow- on research would be required to address those

issues.

DOD also provided technical comments, which we incorporated as

appropriate. DOD's comments are printed in their entirety in

appendix VI. Scope and Methodology

To develop the information in this report, we conducted multiple

literature searches of public and agency databases and reviewed

both published and unpublished literature on the use of adjuvant

formulations in vaccine, including DOD research protocols and

agency documentation. In addition, we interviewed officials at

DOD, NIH, FDA, and the Veterans Administration. We interviewed

vaccine experts in academia,

pharmaceutical firms, and the American Medical Association and

confirmed the validity of using assays as a means of determining

the presence of antibodies. We also interviewed the immunologist

who headed the independent research and laboratory researchers

from Tulane University in New Orleans who developed the anti-

squalene assay, and they shared their methodology and findings

with us. Finally, we interviewed responsible officials at BioPort.

Our work was completed between August 1997 and August 1998 in

accordance with generally accepted government auditing standards.

B-278779 Page 11 GAO/NSIAD-99-5 Gulf War Illnesses

We are sending copies of this report to other interested

congressional committees. We are also sending copies to the

Honorable Cohen, Secretary of Defense; the Honorable Togo

D. West, Jr., Secretary of Veterans Affairs; and the Honorable

Donna E. Shalala, Secretary of Health and Human Services. Copies

will also be made available to others upon

request. If you have any questions or would like additional

information, please contact me at (202) 512- 3092. Major

contributors to this report were Sushil K. Sharma and Dan

. Sincerely yours,

Kwai- Cheung Chan Director, Special Studies

and Evaluations

Page 12 GAO/NSIAD-99-5 Gulf War Illnesses

Contents Letter 1 Appendix I Development of Adjuvant Formulations

With Squalene

15 Appendix II DOD's Clinical Trials on Novel Vaccines With

Adjuvant Formulations Containing Squalene

17 Appendix III DOD's Published Research on Vaccines With Adjuvant

Formulations Containing Squalene That Involved Human Subject

Volunteers

18 Appendix IV DOD's Animal Research on Adjuvant Formulations With

Squalene

19

Page 13 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix V National Institute of Health Studies Using Adjuvants

With Squalene

21 Appendix VI Comments From the Department of Defense

22 Tables Table I. 1: Pharmaceutical Firms' Adjuvant Formulations

That May

Contain Squalene or Squalane 16

Abbreviations

DOD Department of Defense FDA Food and Drug Administration HIV

Human Immunodeficiency Virus IND Investigational new drgus NIAID

National Institute of Allergy and Infectious Diseases NIH National

Institutes of Health

Page 14 GAO/NSIAD-99-5 Gulf War Illnesses

Page 15 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix I Development of Adjuvant Formulations With Squalene

Appendi x I

Biotechnology research and development of adjuvant formulations

with squalene began in the 1970s and the first clinical study

began in 1984. At the time of the Gulf War, at least three firms

Ribi ImmunoChem Research Inc. of Hamilton, Montana; Chiron of

Alameda, California; and Syntex of Palo Alto, California had

developed adjuvant formulations with squalene

and were distributing them for vaccine research and development.

Research on adjuvant formulations with squalene has continued. At

least seven biotechnology and pharmaceutical firms have developed

nine different adjuvant formulations that may contain squalene. In

five of the adjuvant formulations, squalene or squalane is always

a component, and in the other four, it is used optionally (see

table I. 1). According to Chiron, its adjuvant formulation with

squalene has been tested on over 9,000 human subjects. Ribi

ImmunoChem reports that its adjuvant formulations with squalene

have been tested on over 1,000 human subjects.

Appendix I Development of Adjuvant Formulations With Squalene

Page 16 GAO/NSIAD-99-5 Gulf War Illnesses

Table I. 1: Pharmaceutical Firms' Adjuvant Formulations That May

Contain Squalene or Squalane

Note: Much of this information in this table is from F. R. Vogel

and M. V. , Chapter 7, " A compendium of Vaccine Adjuvants

and Excipients, " Vaccine Design: The Subunit and Adjuvant

Approach, M. F. and M. J. Newman, (New York: Plenum Press,

1995). Additional and updated information was gathered from F. R.

Vogel and other sources.

Name of adjuvant formulation

Name of pharmaceutical firm Compound used

Always contains squalane or squalene

Squalene or squalane is used optionally

Antigen Formulation IDEC

Pharmaceuticals Corporation

Squalane Yes No CRL 1005 (Block Copolymer P1205)

Vaxcel Corporation Squalene No Yes Detox RibiImmunoChem Research,

Inc. Squalane Yes No Gerbu Adjuvant CC Biotech

Corporation Squalane No Yes GMDP Peptech, Ltd., UK Squalane No Yes

MF59 Chiron Squalene Yes No MPL RibiImmunoChem Research, Inc.

Squalene No Yes

Ribi adjuvant system RibiImmunoChem Research, Inc. Squalene Yes No

Syntex adjuvant formulation (SAF)

Syntex Research Squalane Yes No

Page 17 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix II DOD's Clinical Trials on Novel Vaccines With Adjuvant

Formulations Containing Squalene Appendi x I I

The following table identifies vaccine trials with adjuvant

formulations that contained squalene and squalane conducted by DOD

under the Food and Drug Administration's (FDA) process for

approving investigational new drugs (IND). New drugs and vaccines

under development generally have to be tested in humans for safety

and efficacy before they are approved for general human use.

Therefore, FDA grants IND waivers allowing human subject

experiments after reviewing information on the product, its

manufacture and testing, and the proposed clinical study.

a Date IND approved by FDA's Human Subject Research Review Board.

b As of December, 1997. c The control group received a placebo

consisting of the adjuvant MF59 alone without the rest of the

vaccine.

Date IND approved for human subject research a IND

number Number of human subjects Country of

subjects Vaccine Adjuvant

containing squalene or squalane

4/ 27/ 88 2699 5 United States Malaria Detox 8/ 8/ 90 3714 12

United States Malaria Detox 12/ 7/ 94 6043 121 b United States

Malaria MPL 2/ 8/ 95 4096 41 vaccine,

13 placebo c Thailand HIV MF59 9/ 18/ 97 7172 300 vaccine,

80 placebo c 377- Thailand 3- United States HIV MF59

Total 5 572 Malaria HIV Detox

MPL MF59

INDs using U. S. citizens 3 138 Malaria HIV Detox

MPL MF59

INDs using foreign citizens 2 434 HIV MF59

Page 18 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix III DOD's Published Research on Vaccines With Adjuvant

Formulations Containing Squalene That Involved Human Subject

Volunteers Appendi x I I I

Rickman, L. et al. " Use of adjuvant containing mycobacterial cell-

wall skeleton monophosphoryl lipid A, and squalane in malaria

circumsporozite protein vaccine. " Lancet. Vol. 337, 1991, pp. 998-

1001. Hoffman, S. L. et al. " Safety, immunogenicity, and efficacy

of a malaria sporozite vaccine administered with monophosphoryl

lipid A, cell- wall skeleton of mycobacteria, and squalene as

adjuvant. " American Journal of Tropical Medical Hygiene. Vol. 51/

5, 1994, pp. 603- 612.

Stoute, J. A. et al. " A preliminary evaluation of recombinant

circumsporozoite protein vaccine against plasmodium falciparum

malaria. " New England Journal of Medicine. Vol. 336, 1997, pp. 86-

91.

Page 19 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix IV DOD's Animal Research on Adjuvant Formulations With

Squalene Appendi x I V

Anthrax Iacono- Connors, L. et al. " Protection against Anthrax

with Recombinant Virus- Expressed Protective Antigen in

Experimental Animals, " Infection

and Immunity. Vol. 59, 1991, pp. 1961- 1965. Ivins, B. et al.

" Experimental anthrax vaccines: efficacy of adjuvants combined

with protective antigen against an aerosol Bacillus anthraces

spore challenge in guinea pigs. " Vaccine, Vol. 13, 1995, pp. 1779-

1784.

Ivins, B. et al. " Experimental Anthrax Vaccines: Efficacy Studies

in Guinea Pigs. " Abstracts of the 93rd General Meeting of the

American Society for Microbiology. 1993, p. 160.

Ivins, B. et al. " Comparative efficacy of experimental anthrax

vaccine candidates against inhalation anthrax in rhesus macaques. "

Vaccine. Vol. 16, 1998, pp. 1141- 1148.

Ivins, B. et al. " Cloned Protective Activity and Progress in

Development of Improved Anthrax Vaccines. " Salisbury Medical

Bulletin Special Supplement. 1990, pp. 86- 88. Ivins, B. et. al.

" Immunization against Anthrax with Bacillus anthraces Protective

Antigen Combined with Adjuvants. " Infection and Immunity. Vol. 60,

1992, pp. 662- 668.

Ivins, B. et. al. " Adjuvant Efficacy in Experimental Anthrax

Vaccines: Protection Studies in Guinea Pigs. " Abstracts of the

91st General Meeting of the American Society for Microbiology.

1991, p. 121.

Ivins, B. et. al. " Vaccine Efficacy of Bacillus Anthraxis

Protective Antigen Produced in Prokayotic and Iukaryotic Cells. "

Abstracts of the 94th General Meeting of the American Society of

Microbiology, 1994, p. 150.

Little S. F. et. al. " Protection against experimental anthrax

infection using fragments of Protective antigen. " Proceedings of

the International Workshop on Anthrax. Vol. 87, 1996, p. 129.

Little S. F. et al. " Passive Protection by Polyclonal Antibodies

against Bacillus anthraces Infection in Guinea Pigs. " Infection

and Immunity. Vol. 65, 1997, pp. 5171- 5175.

Appendix IV DOD's Animal Research on Adjuvant Formulations With

Squalene

Page 20 GAO/NSIAD-99-5 Gulf War Illnesses

Malaria Malik A. et al. " Induction of cytotoxic T lymphocytes

against the Plasmodium falciparum circumsporozoite protein by

immunization with soluble recombinant protein without adjuvant, "

Infection and Immunity.

Vol. 61, 1993, pp. 5062- 5066. Toxic Shock Syndrome Stiles, B. et

al. " Biological Activity of Toxic Shock Syndrome Toxin 1 and a

Site- Directed Mutant, H135A, in a lipopolysaccharide- Potentiated

Mouse Lethality Model. " Infection and Immunity. Vol. 63,1995, pp.

1229- 1234.

Page 21 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix V National Institute of Health Studies Using Adjuvants

With Squalene Appendi x V

a NIAID is the National Institute of Allergy and Infectious

Diseases, AVEG is the AIDS Vaccine Evaluation Group, and DIR is

the Division of Intramural Research.

Date Investigational New Drug (IND) study began Vaccine Institute

IND number Adjuvant with squalene No. of subjects

1/ 28/ 91 HIV NIAID/ AVEG a 005A MF 59 16 3/ 22/ 91 HIV NIAID/

AVEG 005B MF 59 46 10/ 1/ 91 Herpes NIAID/ DIR a 92- I- 0267 MF 59

40 10/ 29/ 91 HIV NIAID/ AVEG 005C MF 59 14 12/ 19/ 91 HIV NIAID/

AVEG 007A MF 59 32 2/ 04/ 92 HIV NIAID/ AVEG 007B MF 59 17 11/ 16/

92 HIV NIAID/ AVEG 007C MF 59 10 07/ 28/ 92 HIV NIAID/ AVEG 008 MF

59 14 10/ 1/ 92 Herpes NIAID/ DIR 93- I- 0141 MF 59 174 12/ 09/ 92

HIV NIAID/ AVEG 201 MF 59 149 5/ 19/ 93 HIV NIAID/ AVEG 012A MF 59

15 6/ 03/ 93 HIV NIAID/ AVEG 015 MF 59 30 6/ 03/ 93 HIV NIAID/

AVEG 015 MPL 30 6/ 03/ 93 HIV NIAID/ AVEG 015 SAF/ 2 30 10/ 1/ 93

Herpes NIAID/ DIR 94- I- 0086 MF 59 18 10/ 12/ 93 HIV NIAID/ AVEG

012B MF 59 59 5/ 11/ 95 HIV NIAID/ AVEG 022 MF 59 59 9/ 14/ 95 HIV

NIAID/ AVEG 024 MF 59 30 10/ 1/ 95 Herpes NIAID/ DIR 96- I- 0024

MF 59 10 7/ 10/ 96 HIV NIAID/ AVEG 022A MF 59 129 2/ 06/ 96 HIV

NIAID/ AVEG 026 MF 59 85 7/ 31/ 96 HIV NIAID/ AVEG 029 MF 59 28 5/

22/ 97 HIV NIAID/ AVEG 202 MF 59 142

Total INDs and subjects 23 1177

Page 22 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix VI Comments From the Department of Defense Appendi x VI

Appendix VI Comments From the Department of Defense

Page 23 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix VI Comments From the Department of Defense

Page 24 GAO/NSIAD-99-5 Gulf War Illnesses (713014) Let t er

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MILITARY VACCINE EDUCATION CENTER // SERIES OF INTERESTING ARTICLES INCLUDING A

COMPLIMENTARY REVIEW ON GARY MATSUMOTO’S BOOK : VACCINE A

….including this excerpt….PAGE 69 (pdf page 78 of 152)

http://www.milvacs.org/News/NewsArchives.cfm

" A number of potential problems with the anthrax vaccine have been suggested,

including problems with quality control during the manufacturing process,335,339

changes in the manufacturing process that may have resulted in increased levels

of active antigen,341 and the use of unapproved adjuvants to bolster the

immunological reactivity of the vaccines.23,340 Reports have indicated that the

anthrax vaccine administered during the Gulf War, commonly referred to as AVA

(anthrax vaccine adsorbed) is associated with a relatively high rate of acute

adverse reactions,342 and have pointed out that there is insufficient evidence

to determine whether the AVA vaccine formulation may be associated with

long-term health sequelae.134,339 "

http://www.milvacs.org/News/NewsArchives.cfm

THERE MAY BE SOME DUPLICATIONS FROM OTHER POSTINGS.

ANTHRAX VACCINE PROBLEMS / RESEARCH / ARTICLES /

http://www.immed.org/

HOUSE REPORT 105-388, 1997 VA,DOD CONTINUE TO RESIST STRONG EVIDENCE LINKING

TOXIC CAUSES TO CHRONIC HEALTH EFFECTS

http://www.gulfweb.org/bigdoc/hsr105-388.cfm

BIOETHICS HISTORY & LINKS TO VACCINE LAWSUITS UNDERWAY

http://www.sskrplaw.com/bioethics/chronology.html

VACCINE LITIGATION

http://www.sskrplaw.com/vaccine/index.html

More DRUG-SAFETY QUESTIONS INCREASE DOUBTS ABOUT FDA 12/20/04

http://story.news./news?tmpl=story2 & u=/usatoday/20041220/cm_usatoday/mo\

redrugsafetyquestionsincreasedoubtsaboutfda

FDA MISHANDLES CHIRON FLU VACCINE PROBLEMS ( Rep. Henry Waxman D-Calif. )

http://www.cidrap.umn.edu/cidrap/content/influenza/general/news/nov2304fda.html

WARNING TO FLU VACCINE MAKER RELEASED/ REPORTS OF “NOT SAFE’/”ADULTERATED

PRODUCT”

http://www.usatoday.com/news/health/2004-12-16-chiron-usat_x.htm?csp=34

VETERANS FREE LEGAL ADVICE SITE ( FAQ’s )/ INCLUDES FORM FINDER TOOL

http://www.advicetool.com/faq/17.html

BONE MARROW CELLS USED IN RESEARCH TO HELP SEVERE LIVER DAMAGE

http://www.newscientist.com/article.ns?id=dn6804

MVAC-PAC Calls Latest Push to Force Anthrax Vaccine Irresponsible Abuse of Power

by the DOD 12/20/04

Is FDA on automatic pilot? 12/20/04

FDA'S sad slide: warnings went unheeded

Chiron Gets Subpoena From US Congressional Committee

http://money.iwon.com/jsp/nw/nwdt_rt.jsp?cat=USMARKET & src=704 & feed=dji & section=n\

ews & news_id=dji-00032820041220 & date=20041220 & alias=/alias/money/cm/nw

Captain Joyce Riley : GULF WAR SYNDROME

http://www.all-natural.com/riley.html

HISTORY OF SECRET EXPIREMENTS IN THE US

http://www.global-conspiracies.com/history.htm

EMERGING INFECTIOUS DISEASES WITH BREAKDOWN BY JOB/RACE/SEX RISKS & GOOD GRAPHS

BY THE NAVY HEALTH RESEARCH CENTER< SAN DIEGO CA. APRIL-JUNE 1998

( HOSPITALIZATIONS FOR UNEXPLAINED ILLNESSES AMONG US VETERANS OF THE PERSIAN

GULF WAR )

http://www.cdc.gov/ncidod/EID/vol4no2/knoke.htm

SECRET GOVT. DATABASE OF ADVERSE REACTIONS TO VARIOUS VACCINES ( $ 25.00 )

http://thinktwice.com/secret.htm

AIR FORCE STUDY BY PUBLIC MED.COM ON AIR FORCE VETERANS

Chronic multisymptom illness affecting Air Force veterans of the Gulf War.

Fukuda K, Nisenbaum R, G, WW, Robin L, Washko RM, Noah DL,

Barrett DH, Randall B, Herwaldt BL, Mawle AC, Reeves WC.

Division of Viral and Rickettsial Diseases, National Center for Infectious

Diseases, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.

CONTEXT: Gulf War (GW) veterans report nonspecific symptoms significantly more

often than their nondeployed peers. However, no specific disorder has been

identified, and the etiologic basis and clinical significance of their symptoms

remain unclear. OBJECTIVES: To organize symptoms reported by US Air Force GW

veterans into a case definition, to characterize clinical features, and to

evaluate risk factors. DESIGN: Cross-sectional population survey of individual

characteristics and symptoms and clinical evaluation (including a structured

interview, the Medical Outcomes Study Short Form 36, psychiatric screening,

physical examination, clinical laboratory tests, and serologic assays for

antibodies against viruses, rickettsia, parasites, and bacteria) conducted in

1995. PARTICIPANTS AND SETTING: The cross-sectional questionnaire survey

included 3723 currently active volunteers, irrespective of health status or GW

participation, from 4 air force populations.The cross-sectional clinical

evaluation included 158 GW veterans from one unit, irrespective of health

status. MAIN OUTCOME MEASURES: Symptom-based case definition; case prevalence

rate for GW veterans and nondeployed personnel; clinical and laboratory findings

among veterans who met the case definition. RESULTS: We defined a case as having

1 or more chronic symptoms from at least 2 of 3 categories (fatigue,

mood-cognition, and musculoskeletal). The prevalence of mild-to-moderate and

severe cases was 39% and 6%, respectively, among 1155 GW veterans compared with

14% and 0.7% among 2520 nondeployed personnel. Illness was not associated with

time or place of deployment or with duties during the war. Fifty-nine clinically

evaluated GW veterans (37%) were noncases, 86 (54%) mild-to-moderate cases, and

13 (8%) severe cases. Although no physical examination, laboratory, or serologic

findings identified cases, veterans who met the case definition had

significantly diminished functioning and well-being. CONCLUSIONS:

Among currently active members of 4 Air Force populations, a chronic

multisymptom condition was significantly associated with deployment to the GW.

The condition was not associated with specific GW exposures and also affected

nondeployed personnel.

PMID: 9749480 [PubMed - indexed for MEDLINE

GULF WAR SYNDROME HEARINGS IN UNITED KINGDOM PARLIAMENT

http://traprockpeace.org/RokkeParliament.html

AUSTALIAN STUDY OF FEMALE GULF WAR VETS

http://www.dva.gov.au/media/publicat/2003/gulfwarhs/html/ch15.htm

AVAIATION/ VIRTUAL FLIGHT SURGEON PAGE/ LOOK UNDER CONCERNS ABOUT THE VACCINE --

it will give interesting info on squalene detection.

http://www.aviationmedicine.com/beta/anthrax_facts.htm

VETERANS BOARD OF APPEALS SEARCH FOUND TWO CASES WITH MICOPLASM FINDINGS

http://www.index.va.gov/search/va/va_search.jsp

AMERICAS CHANGING POSITION ON GULF WAR ILLNESS ( GOOD OVERVIEW )

http://www.mercola.com/2004/nov/17/gulf_war_syndrome.htm

GULF WAR 2 ARTICLE / HEALTH RISKS

http://www.gulfwarvets.com/news13.htm

CONTAMINATION OF PERSIAN GULF WAR VETS BY DU

http://www.antenna.nl/wise/uranium/dgvd.html

REGISTRY OF SPOUSES AND CHILDREN OF GULF WAR VETERANS

http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1007

NEW CASE

http://www.cbsnews.com/stories/2004/03/01/eveningnews/main603284.shtml?CMP=ILC-S\

earchStories

ANTHRAX VACCINE OFFICIAL DOCUMENTS ( PDF Format )

http://www.avip2001.net/OfficialDocuments.htm

TREATMENT FOR GULF WAR ILLNESS

http://my.webmd.com/content/article/62/71644?src=Inktomi & condition=Mental%20Heal\

th

ASSISTANT SECRETARY FOR LEGISLATION GOVT. REPORT CIRCA 2000

http://www.hhs.gov/asl/testify/t001005a.html

INSTITUTE OF MOLECULAR MEDICINE ARTICLE SHOWING 40% OF SICK VETS HAVE

TRANSMITTABLE INFECTIONS ( INCLUDING MYCOPLASMAS )

http://www.immed.org/illness/gulfwar_illness_research.html

Excerpt from the above article as follows :

Gulf War Syndrome or Gulf War Illness has been used to describe a collection of

chronic signs and symptoms reported by U.S., British, Canadian, Czech, Danish,

Saudi, Egyptian, Australian and other Coalition Armed Forces that were deployed

to Operation Desert Storm in 1991. Over 100,000 American veterans of Desert

Storm /Desert Shield (approximately 15% of deployed U. S. Armed Forces) returned

from the Persian Gulf and slowly (6-24 months or more) and presented with a

variety of complex signs and symptoms characterized by disabling fatigue,

intermittent fevers, night sweats, arthralgia, myalgia, impairments in

short-term memory, headaches, skin rashes, intermittent diarrhea, abdominal

bloating, chronic bronchitis, photophobia, confusion, transient visual

scotomata, irritability and depression and other signs and symptoms that until

recently have defied appropriate diagnoses (see publications). These symptoms

are not localized to any one organ, and the signs and symptoms and routine

laboratory test results are not consistent with a single, specific disease.

Although there is not yet a case definition for Gulf War Illness, the chronic

signs and symptoms loosely fit the clinical criteria for Chronic Fatigue

Syndrome and/or Fibromyalgia Syndrome. Some patients have additionally what

appears to be neurotoxicity and brainstem dysfunction that can result in

autonomic, cranial and peripheral nerve demyelination, possibly due to complex

chemical exposures. Often these patients have been diagnosed with Multiple

Chemical Sensitivity Syndrome (MCS) or Organophosphate-Induced Delayed

Neurotoxicity (OPIDN). Chemically exposed patients can be treated by removal of

offending chemicals from the patient's environment, depletion of chemicals from

the patient's system and treatment of the neurotoxic signs and symptoms caused

by chemical exposure(s). A rather large subset (~40%) of GWI patients have

transmittible infections, including mycoplasmal and possibly other chronic

bacterial infections, that have resulted in the appearance of GWI in immediate

family members and civilians in the Gulf region. It is likely that veterans of

the Gulf War who are ill with GWI owe their illnesses to a variety of exposures:

(a) chemical mixtures, primarily organophosphates, antinerve agents and possibly

nerve agents, ( radiological sources, primarily depleted uranium and possibly

fallout from destroyed nuclear reactors, and © biological sources, primarily

bacteria, viruses and toxins, before, during and after the conflict. Such

exposures can result in poorly defined chronic illnesses, but these illnesses

can be treated if appropriate diagnoses are forthcoming.

ANTHRAX VACCINE TESTIMONY ( INCLUDES TESTIMONY FROM AUTHOR TOM HEEMSTRA )

http://www.avip2001.net/CongressionalTestimony.htm

BOOK REVIEW OF VACCINE A by GARY MATSUMOTO

http://www.militaryink.com/books/2004/october/046504400X.htm

http://www.vaccinationnews.com/Scandals/feb_8_02/AnthrVaxRisks.htm

BIOPORT CORPORATE SITE

http://www.bioport.com/

PROBLEMS AT DOVER AFB. LETTER FROM MAJOR SONNIE G. BAITS

http://www.dallasnw.quik.com/cyberella/Anthrax/Starbuck2.html

ANTHRAX VACCINE LINKS

http://www.dallasnw.quik.com/cyberella/

ANTHRAX VACCINE NEWS ARTICLES

http://www.avip2001.net/NewsArticles.htm

10/14/2004 ( NEW ) FOUR INQUIRIES INTO ANTHRAX ALLEGATIONS DEMANDED. DELAWARE

CONGRESSIONAL DELEGATION GIVES RUMSFELD A MONTH TO REPORT ON SQUALINE USE

http://www.delawareonline.com/newsjournal/local/2004/10/15fourinquiriesin.html

MUSLIM CEO’s OF U.S. FIRMS FIGHT TERRORISM “ STOP EVIL “

http://www.usatoday.com/money/2004-05-18-muslim-ceos_x.htm

FDA INSPECTION OF BIOPORT BEGINS

http://www.lsj.com/news/bioport/011213_bioport_1b.html

GREED & GUINEA PIGS :RISKING THE EHALTH OF THE U.S. MILITARY

http://www.militarycorruption.com/greed.htm

US Govt. PATENT ON MICROPLASMA

http://www.gulfwarvets.com/micopat.htm

Mycoplasma Research : MYCOPLASMA FERMENTANS ( incognitos strain )

By Dr’s Garth and Nicolson

http://www.gulfwarvets.com/nicolson.htm

BIOLOGICAL WAREFARE AND VACCINES

http://www.mercola.com/article/anthrax/anthrax_warfare.htm

OFFICIAL ARMY DISPENSATION OF VACCINE FOLKLORE & URBAN LEGEND

http://www.anthrax.osd.mil/resource/qna/qaAll.asp?cID=100

UNIVERSITY OF ALABAMA ANTHRAX VACCINE RESEARCH STUDY

OR HOW TO KILL 300 STUDENTS WITHOUT REALLY TRYING

http://main.uab.edu/show.asp?durki=61718

SQUALINE ANTIBODY STUDY

http://www.autoimmune.com/NewsRel15July02.html

http://www.anthraxvaccine.org/

NEW VACCINE PROBLEMS

http://www.anthraxvaccine.org/problems.html

THE ANTHRAX VACCINE NETWORK

http://www.anthraxvaccine.net/

BIOPORT FDA INSPECTION REPORTS AND DOCUMENTATION

http://www.anthraxvaccine.net/FDA.htm

MORE BIOPORT VACCINE PROBLEMS

http://www.gulflink.org/Vaers/inspection.htm

MANDITORY PARTICIPATION IN MILITARY ANTHRAX VACCINE STUDY

http://www.phoenixnewtimes.com/issues/2000-01-27/feature.html

ANTHRAX VACCINATION PROGRAM EXPOSED

http://www.avip2001.net/

ANTHRAX VACCINES : MAJOR FACTOR IN GULF WAR ILLNESS

http://www.rense.com/general56/gulf.htm

ANTHRAX VACCINE SAFETY & EFFIACY ( Worse than MD 20/20 on a roller coaster ride.

)

http://www.dallasnw.quik.com/cyberella/Anthrax/safety4.html

CHRONIC FATIGUE RELATED STUDIES

http://www.immed.org/illness/fatigue_illness_research.html

AUTOIMMUNE ILLNESS AND DEGENERATIVE DISEASE

http://www.immed.org/illness/autoimmune_illness_research.html

CHRONIC FATIGUE SYMPTOMS

http://www.immed.org/signsympt.htm

LETTERS TO THE INSTITUTE FOR MOLECULAR MEDICINE

http://www.immed.org/letters.htm

CLINICAL TESTING PROCEDURES FOR AUTOIMMUNE DISORDERS ( INTERESTING )

http://www.immed.org/illness/clinical_testing.html

SIGNS AND SYMPTOMS OF THE ABOVE

http://www.immed.org/signsympt.htm

TREATMENT CONSIDERATIONS FOR CHRONIC ILLNESS

http://www.immed.org/illness/treatment_considerations.html

LIST OF NEWS AND MEDIA REPORTS

http://www.immed.org/newsreports.html

WEBSITES THAT ARE USEFUL TO CHRONIC ILLNESS PATIENTS ( HUGE RESOURCE )

http://www.immed.org/weblinks.htm

DEATH OF THE ANTHRAX VACCINE

http://www.angelfire.com/nm/redcollarcrime/anthrax14.htm

ANTHRAX VACCINE CAUSES GULF WAR ILLNESS

http://www.anthraxvaccine.org/AnthraxGWS.htm

COMMITTEE ON GOVERNMENT REFORM

http://reforhm.house.gov/

CHRONIC ANTHRAX

http://www.centurytel.net/tjs11/bug/anth1.htm

GULF WAR ILLNESS

http://www.desert-storm.com/GWI/

BRITISH PROBLEMS WITH ANTHRAX VACCINATIONS

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_uids=1\

2615429 & dopt=Abstract

INFO ON HISTORY OF ANTHRAX VACCINE

http://www.pathlights.com/onlinebooks/chapter4.htm

Pdf File - 24 + anthrax shots in military career

http://www.avip2001.net/OfficialDocuments_files/FlyerR.pdf

MEDICAL INFORMATION NETWORK - PAGES OF INTEREST

http://www2.rpa.net/~lrandall/

********************************************************************************\

********************************************************************************\

********************************************************

SUMMARY OF ANTHRAX VACCINE ISSUES

ANTHRAX VACCINE - SUMMARY OF ISSUES AND OBJECTIONS

HEALTH AND SAFETY (6 shots in 18 mos/annual boosters=24 shots in 20 yrs)

Systemic (Major) Side-Effect Problems with the Vaccine (Requiring Shots be

Discontinued)

- 5/00: Pentagon-funded British study links multiples vaccines in Gulf War

(including anthrax) to

muscle pain, concentration problems, and fatigue -- similar to current reaction

reports

- Vaccine Adverse Event Reporting System (1400 reports) show far more serious

conditions, too

- GAO, 4/29/99: passive VAERS reaction tracking unreliable; causes serious

under-reporting!

- Former FDA Director Kessler says only 1% of reactions ever get reported

- FDA acknowledged that 90% of doctors don't report vaccine reactions

- '70s Swine flu vaccine JAMA analysis: military reports only 1/7th of the

civilian rate

- Active tracking Hawaii study shows 48% systemic reactions--Nearly 250,000

times higher

than an early DOD claim of an unreal .0002%! (Manufacturer claims .2% systemic

rates)

- Korea study: overall reaction rates ~twice as high for women (74%) vs men

(38%)

- GAO report NSIAD-99-5: vaccine may contain a non-FDA-approved adjuvant called

squalene

- DOD policy illegally continues shots after systemic effects in violation of

FDA-approved label

- Documented cases of DOD administering shots from expired lots with serious

health impacts

- February 2000 Institute of Medicine Report indicates insufficient data exists

to determine safety

FDA Approval Process, Inspection Reports, Warning Letters and Lack of Program

Review

- 5/00: FDA refuses to release ~1 million doses because of safety and efficacy

problems!

- 11/99: Vaccine plant fails FDA inspection for the fourth time, many repeat

violations

- Scathing 2/98 FDA 100 page report on vaccine-84 quality control & procedure

violations!

- 25 of 31 lots fail flawed retest; vast inventory (5 million+ doses) still in

quarantine!

- FDA Warning Letters sent to the manufacturer in 1995 & 1997 (threatened to

revoke license)

- SECDEF-chosen program reviewer had no anthrax/vaccine expertise; advised on

marketing

- GAO findings: FDA never evaluated new anthrax strain, new adjuvant,

manufacturing changes,

or efficacy data; need for 6 initial shots/annual boosters unsubstantiated

- FDA removed rotavirus, seldane, and phen-fen for far less; why is this vaccine

still on market?

Disturbing Similarities of Anthrax Vaccine to Government Swine Flu Vaccine

Mistakes in '70s

- 1 swine flu-related death scared gov't because 450,000 died of it in WWI, but

0 anthrax deaths;

- In both cases, antibiotics use de-emphasized;

- probability and severity of occurrence not predictable, incalculable risk

portrayed as inevitable risk;

- no reactions anticipated, but field trials showed poor efficacy/many reactions

(Harvard JFK School of Govt Case Analysis)

- 46 million shots given; 3 Swine Flu Vaccine deaths halted program; 4,000 nerve

damage claims

AN ARBITRARILY MAGNIFIED THREAT

- October '95 DOD meeting indicated a need to " make the case " for anthrax as the

top BW threat

- Conclusions of recent Congressional hearings, reports and book publications on

biowarfare

- threat unchanged in 10 yrs; attack probability overstated; bioweapons very

difficult to manage

- Japan Sarin terrorists had 4 yrs, funds & expertise--no successful anthrax

attacks in 8 tries!

- NY Times reports both the President and Secretary of Defense influenced by

biowarfare fiction

- Serious biodefense: working

detectors/suits/training/masks/filters/antibiotics/decontamination

INEFFECTIVE VACCINE

-USSR & US biowarfare experts Ken Alibek & Bill say vaccines are easily

defeated

- Vaccines could never keep up with anthrax permutations, other biological

agents

- Manufacturer even has application in to FDA for better proof of efficacy; FDA

denying request

- Large 1998 Army mice and guinea pig studies show 90% failure rate against

multiple strains

- Small monkey/rabbit trials with 90%+ survival against one strain are used to

justify the vaccine

- Journal of the American Medical Association: data is lacking for inhalation

efficacy claim

- Senate Staff Report 103-07 says efficacy against inhaled anthrax is " unknown " .

VIRTUALLY NO PUBLIC SUPPORT FOR THE PROGRAM

- Spring 2000 AOL Poll, 83% of those surveyed AGAINST the program (6700

participants)

- 2/18/00 CNN Talk Back Live online query, 85% OPPOSED to the the AVIP program

- 9/99 USA Weekend questionnaire: 83% again AGAINST the program (8000

participants)

- 5/99 Army Times Publishing Company poll -- 77% AGAINST! (military respondents)

- 2/99 TalkSpot KOVR Radio Survey shows 90% of respondents AGAINST the program!

- Statements of Caution/Opposition by Groups representing over 2 million (est)

Americans:

Association of American Physicians and Surgeons, Doctors for Disaster

Preparedness, ROA,

American Legion, American Public Health Association, Air Force Sergeants

Association,

Family Research Council, Soldiers for the Truth, Association of Civilian

Technicians, others.

LEGAL, POLICY, and LOGIC PROBLEMS

- 2 AF Reserve JAGs brief: policy is illegal and based on non-enforceable

DOD/FDA memo

- Senate Staff Report 103-97: vaccine still considered experimental, may be

cause of GWS

- DOD Threat Reduction Agency and State Department -- more risk, but voluntary

shots!

- Forced shots are forcing commanders to play doctor and doctors to play

commander

- Pentagon/Congress are terrorist targets without detection devices; why are

they unvaccinated?

- Khobar Towers/Kosovo message: Combat casualties not acceptable; vaccine

casualties OK!

- Vaccine is a loyalty test; death by flu more likely, but no punishment for

skipping a flu shot

INTERNATIONAL IMPACTS AND EXPERIENCE OF ALLIES

- Erodes '72 BW Convention; encourages BW arms race; de-emphasizes massive

retaliation

- French: Didn't vaccinate in the Gulf War; their military members don't have

Gulf Syndrome

- British: Admit mistakes in Gulf; offered a voluntary vaccine; 73% declined;

program stopped

- Israelis: Don't have a mandatory vaccine policy either; relying on antibiotics

- Canadians: Had mandatory vaccine; recent anthrax vaccine refuser court martial

thrown out

BAD REACTIONS AND IMPACTS ON THE GUARD AND RESERVE

- Reservists couldn't get records, diagnosis, or treatment of vaccine

side-effects from Gulf War

- Reserve members experiencing similar side effects and significant obstacles to

treatment

- Health risks jeopardize civilian income; reservists can't afford vaccine

side-effects!

FAMILY, PERSONAL AND WOMEN'S ISSUES (No vaccination if pregnant)

- Military family members, relatives, friends outraged; many perceive as

assault; way too risky

- Everyone is vaccinated with almost total disregard for medical conditions or

drug interactions

- Some experts advise against vaccinating while nursing; GAO: women studies are

non-existent

- 3 Congresswomen warned SECDEF & HHS of consequences for women of child-bearing

age

MILITARY AND CIVILIAN PILOT OBJECTIONS/ISSUES

- Commercial pilots in Guard/Reserve units faced with taking the shot conduct

serious research

- Between 25-100% aircrew (1000+) refused the shot or plan to based on

discoveries

- Documented reactions could cause pilots serious problems & risk passenger

safety

- Senior aircrew may retire from military; loss of leadership (5000 flying

hours, instructor pilots)

- Younger pilots may just quit the military; won't risk $M airline careers for a

risky vaccine

LIMITATION ON FREEDOM OF RELIGION

- Policy only allows religious objection based on any church doctrine against

ALL vaccines

- No religion, except self-destructive cults, approves of injecting questionable

substances

- National survival is not dependent on disallowing religious objections to this

vaccine!

CONGRESSIONAL INTEREST AND OPPOSITION GROWING

- Senate/House Armed Services Committees hearings: restricting FY 2001 funds for

program

- At least 11 hearings in 1999 on vaccine related issues--5 hearings on this

vaccine resulted in

House Gov't Reform Committee 2/17/00 report recommending suspension of the

program

- 5/14/00 letter to SECDEF by 34 representatives demanding immediate program

halt

- 11/3/99 Congressional letter to FDA: vaccine should be put back in

experimental status

- 7/20/99 Congressional letter to SECDEF states conditions for implementing

program not met

- BIOPORT now under criminal investigation; result of an audit request by Rep

(NC)

- Bioport management abilities questioned at the Congressional hearing on

6/30/99

- Business valuation, DCAA audits, DOD IG show horrid financial mismanagement

- DOD disregarded concerns; awarded $19M (3X requested $) to bail out Bioport,

8/99

- After 11/99 FDA inspection failure, DOD planned another plant $7-10M infusion

- DOD now plans $2.5M/month indefinite bailout!

VACCINE PROFITS AND BUDGET CONSIDERATIONS

- WSJ reports vaccine market potential increased with recent tax, patent and

litigation changes

- Newer/better vaccines and drugs often not developed quickly because they are

less profitable

- Administration BW vaccine stockpile decision included those who would gain

financially

- Insider trading in sale of supplier to Bioport (Adm Crowe); lawsuit dismissed,

facts undisputed

- Budget Black Hole: $.25 Billion Previous/Current + Future Indemnification

Claims + Pilot Replacements + avoidable health care, judicial actions, lost

productivity, recruiting expenditures

CIVILIAN ISSUES AND IMPLICATIONS FOR THE FUTURE

- 1999: 50+ home grown anthrax hoaxes across country cost $millions, affected

13,000, so far

- Administration officials: current vaccine not for civilians, but CDC plans BW

vaccine stockpile

- '97 DOD letter to FDA considers circumventing informed consent for civilians

- Hearings show FDA abdicating responsibility, reviewers with investments,

conflicts of interest

- Anthrax vaccine alone more than doubles # of shots military members receive in

a career!

- $322M budgeted now to develop new biowarfare vaccines; > 15 initially;

potential for 50+

- DOD also studying lab workers who have already received 150-300 shots of

various types!

- Huge health risk potential while we're still spending $134M for 145 projects

to solve GWS

- Where is all this leading? What are limits on the body, recruiting, retention,

fitness and morale?

DOD PRIOR KNOWLEDGE AND IRRATIONAL COMMITMENT

- This issue began as US BW agent sales to Iraq in '80s for " research " which

turned into a threat

- Early '90s news articles identify same issues of informed consent violations,

safety and efficacy

- 10/20/95 & 2/9/94 DOD meetings discovered all major vaccine problems discussed

here!

- DOD indemnification document portrays ineffective vaccine; may cause severe

reactions!

- DOD intends to pursue the anthrax vaccine at all costs once Bioport FDA

approval obtained

CONCLUSIONS

- Government fear-mongering leads to irrational policies and irresponsible, even

criminal actions

- Congressman Shays: The anthrax vaccine program represents " Malpractice and

Malfeasance "

- FDA and DOD pencil-whipped approval/implementation review to expedite use of

old vaccine

- Personal FDA memo does not affect legal vaccine status as unapproved for

airborne anthrax

- DOD's use of the vaccine thus constitutes experimentation; forced shots not a

lawful order

- Many disturbing issues; many unanswered questions; many indications of DOD

callousness

- Solution: Stop the program before service members and national defense suffer

further.

For more information contact:

The National Organization Of Americans Battling Unnecessary Servicemember

Endangerment

NO ABUSE

P. O. Box 70186, Washington, D. C., 20024

202-554-4477

email: kernlhandy@...

Sources researched for this paper include:

1. DOD documents obtained under a Freedom of Information Act Lawsuit filed by

the Veteran's for Integrity in Government and from a Ft Detrick 5/99 anthrax

vaccine meeting

2. Harvard University's JFK School of Government Case Study on the Swine Flu

Vaccine

3. GAO Report # NSIAD-99-5 and 99-148-March & April 1999

4. Original documents on a website established by parents concerned about

reactions their children in the service were experiencing from the

shot--http://www.dallasnw.quik.com/cyberella/

5. Congressional Testimony: www.house.gov/reform/ns/hearings

6. New York Times, " Once He Devised Germ Weapons; Now He Defends Against Them, "

11/3/98

7. Journal of the American Medical Association Articles-Vol 278, #5, p. 402; Vol

275 #3, pp. 241-243

8. DOD Website information and hand-out literature

9. Vanity Fair, Matsumoto, The Pentagon's Toxic Secret, May 1999, p. 82

10. Washington Post Sunday Magazine, Arthur , " Shots in the Dark, " 8/30/98,

p. 11.

11. Gulf War Veterans Website-gulfwarvets.com/

12. Perspectives Magazine, Conrad Istock, " Bad Medicine, " Nov/Dec 1998, p. 21.

13. Dayton Daily News, K.M. Severyn, Ph.D, oncerned Parents Unfairly Shut Out of

Congressional Hearings on Vaccines, " 5/28/93, p. 15A.

14. Nature Magazine, 11/97, p.3.

15. Montreal Gazette, " Military Out of Anthrax Vaccine for gulf Veterans, "

1/22/99, p. 6.

16. Israel Defense Website on biological

weapons-www.webinterview.com/documents/ISREAL0001.htm

17. Conversations with Guard and Reserve members.

18. The Washington Post, S. Greenberg, " The Bioterrorism Panic, " 3/16/99,

p. A21.

19. Air Force News Website-www.af.mil/news/April1999/n1999040*1_990558.html.

20. New York Times, Broad and Judith , " Clinton Seeks More Money

to Counter Germ Warfare, " 6-9-98.

21. Dallas Morning News, Jim Landers, " U. S. Quietly Upgrading Homeland Defense

Plan, " 2/9/99.

22. Wall St Journal, Elsye Tanouye, " The Vaccine Business Gets a Shot in the

Arm, " 2/25/98.

23. State of Michigan, 30th Judicial Circuit Court Case, Docket No. 98-17098-CM.

24. New York Times, Broad and Judith , " Germ Defense Plan in Peril

as Its Flaws are Revealed 8-7-98.

25. New York Times, Broad and Judith , " The Threat of Germ Weapons

is Rising. Fear, Too, " 12/27/98.

26. Washington Post, Brown, " The $115 Million Question, " 11/23/98, p. 15.

27. Army Times, B. Pexton, " A Promise To Do Better Is Not Enough, "

2/2/98, p. 50.

28. JAMA, Vol 281: pp. 1735-1745.

29. http://www.salon.com/health/feature/1999/05/13/anthrax/index1.html.

30. Bangor Daily News, Ruth-Ellen Cohen, " The Anthrax Vaccine, " February, 12,

2000.

31. Letter to SECDEF on AVIP signed by Representatives Gilman, , Ose,

Shays, Souder and Talent, 7/20/99.

32. Secretary of the Army Memorandum of Decision, dated Sept 3, 1998, Subject:

Authority Under Public Law 85-804 to include an Indemnification Clause in

Contract DAMD17-91-C-1139 with Michigan Biologic Products Institute

33. Money Magazine, Rock, " The Lethal Dangers Of The Billion-Dollar

Vaccine Business, " 12/96, Vol. 25, No. 12.

34. Washington Post, Leonard A. Cole, " A Plague of Publicity, " 8/16/99; p. A15.

35. Washington Post, Milton Leitenberg, " False Alarm, " 8/14/99; p. A15.

36. Nov '99 FDA Inspection Report on Bioport facility.

37. Department of Defense comments on the 7/31/97 Federal Register notice

soliciting comments on the Interim Final Rule of 12/21/90, authorizing the

Commissioner of Food and Drugs to determine that obtaining informed consent for

the use investigational new drugs in certain military combat exigencies is not

feasible.

38. Boston Globe, Jeanne Guillemin, " Scare Campaign About Biological Weapons Is

Itself A Threat, " 12/02/99, p. A27.

39. First Annual Report to the President and Congress of the Advisory Panel to

Assess Domestic Response Capabilities for Terrorism Involving Weapons of Mass

Destruction, 12/15/99, pp. 22-26.

40. The Biology of Doom, Ed Regis, 1999.

41. Biohazard, Ken Alibek, 1999.

43. U. S. Department of State Fact Sheet on Chemical - Biological Warfare,

travel.state.gov/cbw.html.

44. Journal of the American Medical Association, 6/2/93, p. 2765.

45. ABC's 20/20 program transcript (1/26/90).

46. Reuters online Health report, 5/18/00.

47. Washington Post, 1/29/91, " Army Faulted on Germ War Research, " p. A17.

48. Washington Post, , " U. S. Troops to Get Germ War Vaccines, "

12/29/90, Page A16.

49. Washington Post, Curt Suplee, " FDA Consents To Use Of Unapproved Drugs On

U.S. Desert Troops, " 12/22/90, p. A10.

50. Washington Post, B. Ottaway, " U. S. Gave Iraq Bacteria, Sen. McCain

Charges, " 1/26/89, p. A16.

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GULF WAR VETS SITE ARTICLE ON ANTHRAX VACCINE SAFETY ISSUES

http://www.gulfwarvets.com/anthrax5.htm

Doctors for Disaster Preparedness

STATEMENT FOR THE RECORD

Submitted by

DOCTORS FOR DISASTER PREPAREDNESS

2509 N.

Box 272

Tucson AZ 85719

(520) 325-2680

Hearings on

U.S. DEPARTMENT OF DEPARTMENT OF DEFENSE

ANTHRAX VACCINE IMMUNIZATION PROGRAM (AVIP)

March 24, 1999

Doctors for Disaster Preparedness is a national organization of physicians and

scientists founded in 1983. We are dedicated to increasing public awareness of

threats from both man-made and natural disasters, and to promoting life-saving

preparedness including homeland defense.

We recognize a serious threat of biological and chemical warfare, as well as the

potential for use of other weapons of mass destruction. The Department of

Defense has responded to this threat by implementing the Anthrax Vaccine

Immunization Program (AVID) to inoculate 2.4 million military personnel.

But the threat is not limited to military personnel engaged in warfare. Last

year, the CDC received reports of a series of bioterrorist threats of anthrax

exposure to domestic civilian targets. These were in the form of letters

purportedly contaminated with the bacillus, or in telephone threats about

contaminated ventilation systems.

Because of the potential exposure of civilians, we are concerned that the

Anthrax Vaccine Immunization Program will be expanded to other diseases or

contaminants, and used as a model for the mandatory vaccination of civilian

children as well as adults

The Assistant Secretary for Defense for health Affairs, Dr. Sue , states

that the AVID is " not primarily a medical program. " Yet the DOD is administering

to our soldiers a medical procedure which raises the following scientific and

medical concerns:

1. VACCINE NO SUBSTITUTE FOR OTHER PROTECTIONS

Because of the wide diversity of agents that could be used, no single vaccine or

combination of vaccines and antidotes is sure to be effective: thus, there is no

substitute for shelter and adequate protective gear. We believe that both

military and civilian populations should have access to the type of NBC shelters

that are standard in Swiss homes.

2. LACK OF CLINICAL STUDIES

While anthrax has long been recognized as a serious threat, having been

weaponized by a number of potential adversaries, currently available anthrax

vaccine falls far short of optimal. The anthrax vaccine was licensed in 1970 on

the basis of one published study, with only five inhalation cases.

Animal studies have shown survival rates as low as 4% and as high as 100% after

anthrax challenge. A 1994 Staff Report for the Committee on Veterans Affairs is

quoted as saying that ``its [the vaccine's] safety, particularly when given to

thousands of soldiers in conjunction with other vaccines, is not well

established'' (Lancet 351:657, 1998, quoting a ProMED-mail posting). The one

U.S. producer, Michigan Biologic Products Institute (now Bioport Corp.), would

have closed last year except for a last-minute plea by the Pentagon, because of

serious concerns about its manufacturing practices.

3. MEDICAL EFFICACY IN DOUBT

Textbooks of military medicine and The Medical Letter (40:52-53, 1998) state

that the anthrax vaccine is ``safe and effective.'' The British secretary of

state for defence was vaccinated on camera in an effort to convince service

personnel and the public of the vaccine's safety. However, several

epidemiologists at the University of Bristol described the state of current

thinking as one of ``clinical equipoise'' and recommended randomizing troops to

receive or not receive vaccine (Br Med J 316:1322, 1998).

Certainly, there is a need to develop a better vaccine. on's Principles of

Internal Medicine states: ``The current vaccines are impure and chemically

complex, elicit only slow-onset protective immunity, provide incomplete

protection, and cause significant adverse reactions.''

4. VACCINE NO DEFENSE AGAINST NEW STRAINS OF ANTHRAX

The vaccine is not completely protective against all natural strains of Bacillus

anthracis. An additional threat in the context of biological warfare is the

potential use of genetically engineered strains, against which both vaccine and

antibiotics may be ineffective (CMAJ 158:633, 1998). Russian scientists have

already produced vaccine resistant strains

5. POTENTIAL IMPACT ON IMMUNE SYSTEM & LINK TO GULF WAR SYNDROME

Anthrax vaccine has been suggested as a possible cause for the Gulf War

Syndrome. While evidence that anthrax vaccine alone can cause such a syndrome

has not been forthcoming, it is possible that the combination of agents may have

induced unexpected adverse changes in the immune response. Additionally,

pertussis vaccine may have been administered as an adjuvant to increase the

immune reactions to other vaccines, especially anthrax (Jamal GA: " Adverse Drug

React " Toxicol Rev 17:1-17, 1998). There is a report that the anthrax-pertussis

combination induced ``severe loss of condition and weight'' in animals (Nature

390:3, 1997).

6. POOR RECORD KEEPING & FOLLOW UP STUDIES

Fear and mistrust are fueled by poor record-keeping about chemical exposures and

vaccines in the Gulf War. There are no adequate records of recipients of special

immunizations not in general use (anthrax and botulinum) (Wegman DH et al.: Am J

Epidemiol 146:704-711, 1997). The British defence ministry has also admitted

that ``medical record-keeping in the Gulf was not satisfactory,'' according to

researcher Alan Silman of the University of Manchester (Nature 384:604, 1996).

Moreover, ``the MOD [ministry of defence] suffers from an excessive culture of

secrecy'' (Nature 390:3- 4, 1997).

7. EXPANSION OF MANDATORY VACCINES TO CIVILIAN SECTOR

The questions raised about adverse reactions due to vaccine cocktails are highly

pertinent in the civilian sector, now that such a large number of vaccines are

mandated for administration to children, with exclusion from school and even

charges of child neglect or abuse as penalties for noncompliance.

RECOMMENDATIONS & CONCLUSION

Because of the limited efficacy of the anthrax vaccine, prevention of exposure

with shelters and protective gear remains indispensable. In addition to improved

vaccines with limited toxicity, the Department of Defense should consider more

advanced and less invasive tools, such as decontamination agents.

For example, a material developed by D. Craig of Novavax, Inc, which may

be able to rapidly destroy a wide variety of dangerous bacteria and viruses,

including anthrax spores. The material, called BCTP, is made from water, soybean

oil, Triton X 100 detergent, and the solvent tri-n-butyl phosphate. Laboratory

mice and rats thrive when fed the material. Rapid inactivation of anthrax

bacteria and spores combined with low toxicity could make BCTP a promising

candidate as a broad-spectrum post exposure decontamination agent.

In summary, better passive protection measures and expanded research into

vaccines are urgently needed. At present, mandatory vaccination of all troops

with the available anthrax vaccine has raised a number of well-founded concerns

that should be addressed openly. Our organization is available for any questions

or concerns of this committee.

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ARMY VACCINES & GULF WAR SYNDROME

The Vaccines Anthrax vaccine

[Jan 2003] GULF WAR ILLNESS SHOCKER

159,238 US Gulf War I Casualties

Gulf War Vaccines

[Media UK, May 2003--Osteoporosis] Soldier hails Gulf case win

[Media UK, April 2003] GULF WAR JABS 'LIES' BY HOON

[Nov 2002] NEW BOOK- About the Gulf War and the Problems

Testimony of B. Urnovitz, Ph.D. (1/24/02)

Testimony of B. Urnovitz, Ph.D. (2/2/00)

TESTIMONY OF DR. HOWARD B. URNOVITZ August 3, 1999 COMMITTEE ON GOVERNMENT

REFORM AND OVERSIGHT

Dr Urnovitz interview Dec 1999 CFS Radio

A Lecture By Captain Joyce Riley in Houston, Texas on January 15, 1996

The Gulf Bio War: How a New AIDS-like Plague Threatens Our Armed Forces by Alan

R. Cantwell, Jr., M.D.

[Media July 2001] Illegal vaccine link to Gulf war syndrome

" Similarly, U.S. legislators learned in 1999 the little reported fact that Gulf

War troops, as many as 200,000, were unwittingly used in AIDS vaccine

experiments wherein portions of the AIDS virus, HIV, were recombined with a

pathogenic mycoplasma, isolated, tested, and then patented by Dr. Shyh-Ching Lo

of the Armed Forces Institute of Pathology for the American Registry of

Pathology in Washington, D.C. The patent is reprinted and discussed in this

authors book, Healing Codes for the Biological Apocalypse (Tetrahedron

Publishing Group, 1999). " --Dr Horowitz

Possible Link Between the Administration of Multiple Thimerosal Containing

Vaccines, Stress Induced Increases in Blood-Brain Barrier Permeability and Gulf

War Syndrome http://www.altcorp.com/gulfwar.htm

Interview with Dr Nicolson

Role of bioengineering in CFS, GWS & AIDS--Dr Mazlen

Vaccine cocktail and stress ‘doomed Gulf War heroes (May 2000)

Statement on anthrax vaccine safety

STATEMENT OF SONNIE G. BATES, MAJOR, USAF (Anthrax vaccine--Burton hearings)

Statement by Major L. Rempfer

Media 8/99: Secret vaccine sparks new fear for Gulf vets

Anthrax Vaccine Links and Information

http://www.dallasnw.quik.com/cyberella/index.htm

VACCINES & AIDS: Interview of Dr Eva Snead by Lee on September 19th 1992.

Anthrax vaccine, possible dangers http://www.nccn.net/~wwithin/anthrax4.htm#TOP

Experimental vaccine and Gulf War syndrome

http://www.new-atlantean.com/global/ith_gulf.html

http://www.new-atlantean.com/global/secret.html

Objection to Gulf War vaccine was overridden

http://www.ohio.com/bj/news/ohio/docs/029677.htm

Anthrax vaccine: Cure or Conspiracy? http://www.gulfwarvets.com/vaccine.htm

Vaccine guinea pigs http://www.gulfwarvets.com/winds.htm

http://home.sprynet.com/sprynet/Gyrene/gulfwar.htm

Gulf War Syndrome Pg.6 http://pathfinder.com/Life/essay/gulfwar/gulf06.html

GWS Link To Innoculations found http://www.sonic.net/daltons/melissa/gws5.html

Health threat from bioweapons http://physlab.web2010.com/bio/bw.htm

Germ Warfare against America http://physlab.web2010.com/bio/mcv.htm#Top

Gulf War Forced Inoculations http://www.all-natural.com/gwi-1.html

Null http://www.garynull.com/documents/GulfWarLegacy2.htm

Bosnia:

Army misled troops http://www.cleveland.com/news/pdnews/frontpage/oabosnia.htm

Experimental vaccine http://home.sprynet.com/sprynet/Gyrene/bosnia.htm

Department of Defense, Navy, and national immunization policies and practice.

http://www-nehc.med.navy.mil/prevmed/immun/imunmain.htm

GULF WAR SYNDROME http://www.new-atlantean.com/global/ith_gulf.html

http://www.immed.org/ http://members.aol.com/rgm1/private/nicolson.htm

http://www.all-natural.com/gwi-1.html http://www.trufax.org/menu/gulf.html

http://www.techmgmt.com/restore/gulfwarp.htm

http://www.insigniausa.com/gulflink.htm http://www.dtic.mil/gulflink/

Mission Impossible http://www.dorway.com/possible.html

Is Desert Storm Syndrome NutraSweet Disease?

http://www.dorway.com/betty/deserts.txt

[Vaccines]

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Administrator posted November 20, 2003 21:54

http://courant.ctnow.com/projects/anthrax/

Story Archive: 1994-2000

--------------------------------------------------------------------------------

Pilot Who Refused Shots May Face Court-Martial

The Air Force decided Thursday to go forward with the controversial

court-martial of one of the highest-ranking officers to refuse to be inoculated

with the anthrax vaccine.

Lawmaker: Testimony On Vaccine May Have Prompted Retaliation

A U.S. congressman, the chairman of a committee investigating the health effects

of the military's anthrax vaccine, is seriously concerned over the Air Force's

push Friday to court-martial one of the committee's key witnesses, a spokeswoman

said Saturday.

Major May Face Court-Martial

A flurry of communications among a powerful congressman, the Pentagon and a U.S.

Air Force major finally led Friday to a decision by the Air Force to proceed

toward court-martialing the major for refusing to take the anthrax vaccine.

Was Toxic Plutonium Dust On Gulf War Battlefield?

A Persian Gulf War veterans' advocacy group says the Pentagon probably used

plutonium in ammunition and tank coatings that during wartime explosions emitted

toxic smoke and dust, sickening many of those exposed.

Marine Who Lost Vaccine Fight Is AWOL

A U.S. Marine Corps private who two weeks ago lost his legal challenge to the

military's mandatory anthrax vaccination program is missing from duty.

Failed Inspection Slows Military's Anthrax Vaccine Program

Critics of the military's anthrax vaccination program are saying the failure of

the manufacturer's new plant to pass a federal inspection is yet another reason

the program should be halted.

Mandatory Anthrax Vaccine On Trial

A U.S. Marine headed Thursday into U.S. District Court in Pittsburgh, reportedly

the first to legally challenge the Pentagon's mandatory anthrax vaccination

program.

Anthrax Study Request Refused

Federal health authorities are refusing a request by four congressmen, including

Connecticut Republican Shays, that they further study the anthrax

vaccine as an experimental drug.

State's Air Guard Off Schedule for Anthrax Shots

The Connecticut Air National Guard has insisted for months that it is 90 percent

in compliance with deadlines for anthrax vaccinations. But figures supplied to

Congress recently show the local guard unit was close to 90 percent out of

compliance for one shot of the series alone.

Military Anthrax Shots A Prickly Subject

Lawmakers heard vastly different takes Wednesday on the effect a mandatory

anthrax vaccination program is having on the ranks in the nation's National

Guard and reservists.

Anthrax Shots Put On Hold At Base

Hurricane Floyd was a hazard to thousands on the East Coast, but it was a relief

for many of the 600 members of the Air National Guard in Newburgh, N.Y., who

were scheduled to take anthrax shots.

Program Lags in Battle Against Anthrax

Large percentages of people serving in military reserve and National Guard units

are not receiving their mandatory anthrax vaccinations as required under

stringent schedules, military documents show.

Anthrax Vaccine Deal Criticized

A Pentagon deal allowing the manufacturer of the controversial anthrax vaccine

to more than double the price of the shots and receive an $18.7 million

interest-free advance payment is drawing fire from military watchdogs, soldiers

and members of Congress.

Defense Secretary Called Lax In Vaccine Case

Six congressmen, including Connecticut's U.S. Rep. Shays, say a

congressional inquiry shows that Secretary of Defense S. Cohen failed to

carry out plans to ensure the safety of the anthrax vaccinations for all 2.4

million U.S. troops.

Service Members Tell Panel Of Anthrax-Shot Complications

Jon Richter's health troubles started shortly after he took his second shot of

the military's mandatory anthrax vaccine Feb. 19. A transport jet pilot in the

reserves at Delaware's Dover Air Force Base, Richter dutifully took part in the

program, despite rumors of nasty side effects and concerns about the vaccine.

Anthrax Vaccine's Safety Questioned

Newly obtained U.S. Army and other military documents raise questions about the

anthrax vaccine's safety and effectiveness in light of the positive way the U.S.

Department of Defense has been advertising the vaccine.

Pentagon Official Tells Congress Anthrax Vaccine Is Safe

A top Pentagon official told Congress Wednesday that the controversial anthrax

vaccine is safe, despite an Army memorandum that voices concerns about possible

adverse health effects on American troops now required to receive it.

Military Knew Of Vaccine's Hazards

The secretary of the U.S. Army conceded in a September 1998 memo that the

anthrax vaccine eventually to be administered to 2.4 million service people

could cause adverse reactions and might not even protect some against anthrax

attacks.

Anthrax Shots Are Resumed After Hiatus

A commander at Dover Air Force Base in Delaware became the highest-ranking

member of the military to defy the Defense Department when he suspended most

anthrax vaccinations at his base last week. But Col. Felix M. Grieder's stand

was short-lived.

Doctors Politicians Boost Opposition To Pentagon's Vaccine Policy

More than a year into its mandatory anthrax vaccination program, the U.S.

military finds itself facing challenges from the medical community, some members

of Congress and a growing number of its servicemen and women.

Anthrax Vaccine Debate Moves To Congress

The Department of Defense is in the midst of an effort to immunize all 2.4

million active duty personnel against deadly anthrax spores, potentially spread

by enemy troops or terrorists. The estimated cost of the inoculations -- the

first attempt to protect the entire military against a germ warfare agent -- is

$130 million.

Pilots Quit Guard Unit In Anthrax Argument

Eight veteran combat pilots from the Connecticut Air National Guard -- almost a

quarter of the 103rd Fighter Wing -- are resigning to protest a requirement that

they be inoculated with a controversial anthrax vaccine.

Military Anthrax Shot Challenged

A dispute has arisen over recent use of the anthrax vaccine to protect U.S.

troops from biological warfare during the military deployment in the Persian

Gulf area.

Defense Documents Support Claims Of Gulf War Veterans

U.S. Department of Defense documents contradict the Pentagon's assertions that

Persian Gulf War soldiers were not exposed to Iraqi chemical or biological

weapons.

Experimental Drugs Cited In Gulf War Illnesses

Experimental drugs and vaccines used to protect U.S. soldiers in the Persian

Gulf War may have caused the mysterious illnesses plaguing some of them since.

Many soldiers received anthrax shots to protect them from biological warfare,

and anti-nerve-agent pills, called pyridostigmine, to shield them from nerve

gas.

Gulf War Veteran Seeks Army Recognition Of Syndrome

Gulf war veteran M. Guerrette is tired, demoralized - and waging the fight

of his life. Like thousands of other gulf war veterans, the 33-year-old

Willimantic native thinks he got sick in the war against Iraq. He's not sure

exactly how.

IP: Logged

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Administrator posted November 20, 2003 21:56

http://courant.ctnow.com/projects/anthrax/

Anthrax Vaccine:

Care Or Curse?

The Vaccine:

A treatment designed to protect against anthrax, a livestock disease that is

almost 100 percent fatal to humans.

Why Use It?

The Pentagon says vaccination of military personnel is necessary to guard

against one of the world's top biological warfare threats. Anthrax is considered

the easiest germ weapon to make and use. It can be produced in a dry form that

can be ground into tiny particles and stored. When inhaled, the particles can

cause severe pneumonia and death within a week.

Why Resist It?

Critics question the safety and effectiveness of the vaccine, saying a link may

exist between diseases developed by Persian Gulf War veterans and anti-anthrax

shots administered to 150,000 U.S. troops who served in the 1991 conflict. Their

worries were reinforced when Food and Drug Administration inspectors said

testing and record-keeping at the Michigan plant that produces the vaccine did

not meet federal standards.

IP: Logged

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Administrator posted November 20, 2003 21:58

http://www.ctnow.com/news/specials/hc-anthrax-detrick.storygallery?coll=hc%252

SPECIALS

Anthrax Attacks

Dozens of scientists are under scrutiny because they had access to the strain of

anthrax used inlast fall's anthrax attacks and the knowledge to use it as a

weapon. But so far, Dr. J. Hatfill is the only one who has been publicly

served with a search warrant.

October 9, 2002

An Anthrax Widow May Sue U.S. - Hartford Courant

Ineligible for financial aid to victims of Sept. 11 and angry over signs that an

Army lab may have unwittingly provided the anthrax that killed her husband last

fall, the widow of a Florida tabloid editor is exploring a lawsuit against the

federal government.

September 7, 2002

Anthrax Killer Outlasting Hunters - Hartford Courant

Five months after the deadly anthrax letters were mailed last fall, FBI

investigators finally got around to subpoenaing laboratories that worked with

the Ames strain used in the attacks.

September 4, 2002

Hatfill Fired From Job - Hartford Courant

The former army scientist at the center of the FBI's anthrax investigation was

fired Tuesday from a government-funded teaching job at Louisiana State

University.

August 14, 2002

New Anthrax Clue, Same Hatfill Focus - Hartford Courant

On the heels of the first big break in the anthrax investigation in months --

the discovery of a New Jersey mailbox where the anthrax-laced letters may have

been mailed -- federal agents Tuesday blanketed the area flashing a picture of

the man they have refused to call a suspect.

August 12, 2002

Hatfill Speaks Out - Hartford Courant

The man at the center of the FBI probe of last fall's anthrax attacks launched a

public campaign this weekend proclaiming his innocence and trying to quell what

he described as a humiliating ``feeding frenzy'' for information about his

personal life.

August 2, 2002

Scientist Again Under Scrutiny - Hartford Courant

FBI anthrax investigators are turning up the heat on former Army bioterrorism

scientist Hatfill, searching his land apartment for a third time

Thursday and questioning students who attended an African medical school with

Hatfill 20 years ago.

June 28, 2002

Hatfill Teaching Bioterrorism Course - Hartford Courant

J. Hatfill, the microbiologist at the center of the FBI's anthrax

investigation, has been working as part of an $11.5 million government-funded

program to train police and firefighters in the event of a bioterrorism attack.

June 13, 2002

Anthrax Theory Emerges - Hartford Courant

The FBI is investigating whether the anthrax spores used in last fall's attacks

could have been grown secretly inside an Army lab and then taken elsewhere to be

weaponized, according to three sources familiar with the ongoing probe.

February 1, 2002

Most Samples Tracked: Anthrax Still Missing - Hartford Courant

The Army has been unable to locate an anthrax specimen that disappeared from its

biowarfare research institute 10 years ago, although it now can account for most

of 26 other lab samples that went missing, an Army spokesman said Thursday.

January 20, 2002

Anthrax Missing from Army Lab - Hartford Courant

Lab specimens of anthrax spores, Ebola virus and other pathogens disappeared

from the Army's biological warfare research facility in the early 1990s, during

a turbulent period of labor complaints and recriminations among rival scientists

there, documents from an internal Army inquiry show.

December 20, 2001

Anthrax Easy to Get Out of Lab - Hartford Courant

Pink-slipped in 1997 after 11 years working with the world's deadliest toxins at

the Army biodefense lab in Fort Detrick, Md., Crosland reluctantly

packed a box of personal items into his red Mustang and drove home.

December 19, 2001

Turmoil in a Perilous Place - Hartford Courant

Days before the anthrax attacks became known, Dr. Ayaad Assaad sat terrified in

a vault-like room at an FBI field office in Washington, D.C. The walls were gray

and windowless. The door was locked. It was Oct. 3.

December 6, 2001

Anthrax Investigation Tracks Vaccinations - Hartford Courant

The FBI has asked laboratories around the country for records of workers

vaccinated against anthrax, as investigators pursue a growing suspicion that

whoever mailed the anthrax-laden letters in New Jersey must have taken

extraordinary steps to avoid dying in the process.

What You Need To Know About Anthrax - Hartford Courant

View our information on Anthrax.

October 24, 2001

Anthrax: Questions, Answers - Hartford Courant

Q. How are people infected?

October 23, 2001

What You Need to Know About Anthrax - Newsday

Here is a collection of stories, photos, graphics and links to health websites

with answers about anthrax and its treatment.

IP: Logged

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Administrator posted December 05, 2003 23:22

http://www.ngwrc.org/anthrax/default.asp

Welcome to the Anthrax Vaccine Network

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ANTHRAX VACCINE GOVT. INFORMATION

http://www.avip2001.net/GovernmentInformation.htm

ANTHRAX SHOTS DRIVE AIR FORCE VETERAN FROM THE SERVICE

http://www.avip2001.net/OfficialDocuments_files/MA.htm

LETTERS OF OPINION/ATTEMPTS TO INFORM GOVT. OFFICIALS

http://www.avip2001.net/Opinion.htm

MORE ANTHRAX VACCINE SITES

http://www.avip2001.net/InformativeWWWSites.htm

BOOK REVIEW ON “VACCINE A” - By GARY MATSUMOTO/CNN Special Reporter

http://www.vaccine-a.com/

BOOK REVIEW ON “ ANTHRAX - A DEADLY SHOT IN THE DARK “ by TOM HEEMSTRA

Web Won't Let Government Hide

Given the government keeps tabs on the world using armies of agents, algorithms

and wiretaps, how can a citizen compete? Try a browser. Governments at every

level these days are providing less information about their inner workings,

sometimes using fear of terrorism as an excuse. But it's precisely times like

these that mandate citizens' rights to check the efficiency of their government

and hold those who fail accountable, open government advocates say. The

government itself won't make it easy, so an increasing number of websites and

data crunchers are stepping in to provide information about the inner workings

of government. For starters, there's Google's little-known government specific

search engine. One can even find homeland security alerts about truck bombs

(PDF) and the intelligence needs of the FBI. Another trove of information is

Washington University's National Security Archive, which contains

thousands of documents acquired through patient Freedom of Information

Act requests. And there's CoolGov, a blog devoted to ferreting out quirky

tidbits such as videos of airline crashes. Those interested in the nitty-gritty

of how and why the government hides information can subscribe to

Aftergood's Secrecy News listserv, which is part of his work as the director of

Federation of American Scientists' Project on Government Secrecy. Aftergood, who

publishes a couple times a week, has built up an archive of previously

unpublished reports created for Congress and information about the CIA's ongoing

opposition to the publication of its budget. Hoofnagle, a lawyer for the

Electronic Privacy Information Center (which is known for its prowess with

Freedom of Information Act requests), calls Aftergood's work a must-read for

anyone interested in a " nuanced interpretation of government information

policy. " Aftergood uses FOIA requests only sparingly though, calling them

cumbersome, relying instead on contacts and tips. " Information has

gravitational properties, " Aftergood said. " Over time, more and more

information flows to me. " When asked what motivates him, Aftergood gives both a

principled and pragmatic answer. " Openness is essential to self-government, "

Aftergood said. " If we mean to be our own rulers, then we need access to

information. What keeps me going, though, is that, fortunately, a lot of this

work is fun -- it is fun to collect information and to share it with like-minded

others and to discover that small groups of interested citizens can be more

effective and agile than large government bureaucracies. " Aftergood is not the

only one-man information bank on the internet. Russ Kick keeps information alive

at The Memory Hole, where he archives documents pulled from government websites.

He is famous for successfully using FOIA to obtain and publish photos of

American soldiers' coffins being unloaded at the Dover Air Force Base. " We

aren't experts, so if we can find it -- these folks are much smarter than

we give them credit for, they are almost certain to already have it, " Young

said. " They use the internet avidly and have a lot more time to do this than I

do. If I can find it and not let it be known, it creates a greater hazard. "

EPIC's Hoofnagle sees these efforts as part of an " overall system that has a

skeptical worldview of government action. " " Our FOIA work has proven it pays to

be skeptical, " Hoofnagle said. " EPIC is perhaps best known for our FOIA requests

into the Carnivore system, which the FBI described as a precise and surgical

computer forensic tool that turned out to be more like a vacuum cleaner. " Unless

one can put their hands on the actual agency documents, the public has to rely

upon representations that may be jaundiced.

posted December 19, 2004 11:41

You can be tested for ASA (Anti-Squalene Antibodies), however I don't know if

the VA will test for this. I would call the VA/Environmental Agents Service near

you and ask if they can test you for it.

http://www.milvacs.org/Sick/Mycoplasm.cfm

Squalene, an orgamic polymer which occurs naturally in the human body, is, in

remanufactured form, an adjuvant, or vaccine " booster, " used in several

experimental vaccines. The purpose of such an adjuvant is to boost the immune

system's reaction to the vaccine. It is illegal for use on human beings in the

United States and Great Britain. There is evidence that when injected, squalene

is responsible for arthritic conditions and pain. Squalene appears to be highly

reactive when injected, although not as reactive when ingested orally.

Although the Dept. of Defense denied the presence of Squalene in the anthrax

vaccine for many years, the FDA tested several lots for the presence of the

adjuvant, and found it - in varying levels. Those lots are (ppb=parts per

billion):

AVA 020 - 11 ppb squalene

AVA 030 - 10 ppb squalene

AVA 038 - 27 ppb squalene

AVA 043 - 40 ppb squalene

AVA 047 - 83 ppb squalene

Squalene has also been found in the vaccine administered in Great Britain,

although the Ministry also denied its presence. See MOD (Ministry of Defense -

UK - ANTHRAX VACCINE CONTAINS SQUALENE)

Recent research by Pamela B. Asa, B. , and F. Garry links

the anthrax vaccine to Gulf War Syndrome through the presence of squalene

antibodies, as noted in the introduction to their report:

" Date: 2002-07-15 Received August 15, 2001, and in revised form October 26,

2001 "

" We previously reported that antibodies to squalene, an experimental vaccine

adjuvant, are present in persons with symptoms consistent with Gulf War Syndrome

(GWS) (P. B. Asa et al., Exp. Mol. Pathol 68, 196-197, 2000). The United States

Department of Defense initiated the Anthrax Vaccine Immunization Program (AVIP)

in 1997 to immunize 2.4 million military personnel. Because adverse reactions in

vaccinated personnel were similar to symptoms of GWS, we tested AVIP

participants for anti-squalene antibodies (ASA). In a pilot study, 6 of 6

vaccine recipients with GWS-like symptoms were positive for ASA. In a larger

blinded study, only 32% (8/25) of AVIP personnel compared to 15.7% (3/19) of

controls were positive (P 0.05). Further analysis revealed that ASA were

associated with specific lots of vaccine. The incidence of ASA in personnel in

the blinded study receiving these lots was 47% (8/17) compared to an incidence

of 0% (0/8; P 0.025) of the AVIP participants receiving other lots of vaccine.

Analysis of additional personnel revealed that in all but one case (19/20; 95%),

ASA were restricted to personnel immunized with lots of vaccine known to contain

squalene. Except for one symptomatic individual, positive clinical findings in

17 ASA-negative personnel were restricted to 4 individuals receiving

vaccine from lots containing squalene. ASA were not present prior to

vaccination in pre-immunization sera available from 4 AVIP personnel. Three of

these individuals became ASA positive after vaccination. These results suggest

that the production of ASA in GWS patients is linked to the presence of squalene

in certain lots of anthrax vaccine. 2002 Elsevier Science (USA) "

********************************************************************************\

******************************************************

THE FOLLOWING ARTICLE COME FROM A HOMELAND SECURITY FORUM

Posted: Mon Dec 27, 2004 12:46 pm Post subject: VACCINES -Clinton Orders Human

Experiments December 27, 2004

VACCINES - Clinton Orders Human Experiments

By W. Maier

A day after Republican Rep. Shays of Connecticut ended congressional

hearings on the controversial decision mandating the inoculation of 2.4 million

U.S. troops against anthrax, President Clinton quietly signed an executive

order, or EO, that denies soldiers the right to refuse experimental vaccines.

EO13139, titled " Improving Health Protection of Military Personnel Participating

in Particular Military Operations, " caught Congress off guard as it directed the

Pentagon to disregard the authority of the Food and Drug Administration, or FDA.

The order authorized use of experimental vaccines - those not approved by the

FDA and therefore illegal - to be administered to members of the armed forces

without informed consent.

Some congressmen saw this as an attack by the president on the House Government

Reform subcommittee on National Security, Veterans Affairs and International

Relations, where testimony indicated the Pentagon had violated the FDA's

procedures on how to administer the anthrax vaccine. Those hearings - as well as

others held by the full House Committee on Government Reform - had put the FDA

on the spot for letting the Pentagon disregard sensible FDA regulations. The

Pentagon wanted to administer the shots now and, as a result, long-range studies

were not conducted and an inadequate reporting system was set up to hide the

large number of adverse effects, critics charged.

As a result of the unprecedented implementation of the vaccination program, more

than 1,000 troops are awaiting trial on a felony charge of refusing to obey,

hundreds more have left the armed forces and dozens have been prosecuted.

The FDA's failure to take a stand against the Pentagon has prompted a group of

concerned congressmen, led by Republican Rep. Walter Jr. of North

Carolina, formally to complain to the agency. " The FDA didn't do its job, " says

, a member of the House Armed Services Committee. " Our men and women are

too valuable and they're not going to be guinea pigs. "

, who has asked the Pentagon's inspector general to launch a probe into the

growing anthrax controversy, warns that Clinton's executive order " might

encourage more men and women to get out of the military. I think Clinton did it

to give cover to what the DOD [or Department of Defense] is doing. " And with the

FDA having rolled over, says, he is even more determined to learn why the

White House and the Pentagon doubled the contract of Michigan-based BioPort

Corp., which manufactures the vaccine, from $25.7 million to $49.8 million and

at the same time reduced the volume to be delivered by 2.3 million shots (see

" Why BioPort Got a Shot in the Arm, " Sept. 20).

The Pentagon has claimed the inoculation protects against all anthrax strains,

and BioPort made the same claim to Insight - despite the fact that an experiment

at the Fort Detrick chemical and biological warfare center in land using

guinea pigs showed nine of the 27 anthrax strains tested killed 50 percent of

the vaccinated subjects.

…for more on this article and other posts go to

www.hspig.org/ipw-web/bulletin/bb/viewtopic.php?t=1930

SITES ABOUT SOLDIERS USED IN GOVT> TEST PROGRAMS

http://projects.sipri.se/cbw/research/ssf-cwc-fs-eif.html

http://www.wsws.org/articles/2004/dec2004/port-d11.shtml

http://www.ceip.org/files/publications/Harigelreport.asp?p

http://www.rand.org/publications/MR/MR1018.5/MR1018.5.pdf/MR1018.5.ch1.pdf

http://www.nnn.se/vietnam/health.pdf

http://www.bordeninstitute.army.mil/cwbw/Ch8.pdf

http://www.fpif.org/briefs/vol1/chem_body.html

http://www.asanltr.com/newsletter/02-1/articles/021d.htm

http://www.leaonline.com/doi/abs/10.1207/S15327876MP1402_5;jsessionid=jaIPVNgaD7\

h-?cookieSet=1

http://www.iupac.org/publications/pac/1995/pdf/6705x0841.pdf

http://www.iupac.org/publications/pac/1995/pdf/6705x0841.pdf

http://www.nap.edu/books/030904832X/html/131.html

http://www.nap.edu/books/030904832X/html/21.html

http://ccrweb.ccr.uct.ac.za/archive/two/10_3/biological.html

http://www.loc.gov/rr/scitech/tracer-bullets/chemicalbiotb.html

http://www.nbc-med.org/SiteContent/HomePage/WhatsNew/MedAspects/Ch-3electrv699.p\

df

http://www.csis.org/burke/hd/reports/Buffy012902.pdf

http://www.wws.princeton.edu/cgi-bin/byteserv.prl/~ota/disk1/1993/9346/934604.PD\

F

http://www.bordeninstitute.army.mil/cwbw/Ch12.pdf

http://www.opcw.org/docs/csp9/c9dec03.pdf

http://www.wws.princeton.edu/cgi-bin/byteserv.prl/~ota/disk1/1993/9346/934604.PD\

F

http://www.opcw.org/docs/csp9/c9dec03.pdf

http://www.cepis.ops-oms.org/tutorial1/fulltex/armas/bioweapons/bioweapons.pdf

The above web sites are mostly from US Government sponsored research or from

internationally known organizations and their research is accepted world wide.

Marilyn s article on Anthrax Vaccines

http://www.hspig.org/ipw-web/bulletin/bb/viewtopic.php?t=1864

________________________________________________________________________________\

________________________________________________________________

List of U.S. Veteran Web Sites

http://members.aol.com/veterans/warlib6.htm

http://www.vetfriends.com/organizations/index.cfm

List of Veterans Service Organizations

http://www.vasthcs.med.va.gov/vso.htm

List of U.S. Radio and Television Stations

http://www.journalismnet.com/radio/us.htm

List of U.S. Colleges

http://www.cs.queensu.ca/FAQs/email/country/United-States-of-America-C.html

List of U.S. Newspapers

http://www.usnpl.com/

List of Congressional Members

http://www.webslingerz.com/jhoffman/congress-email.html

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88888888888888888888888888888888888888888888888888888888888888888888888888888888\

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Breakthrough on Gulf War Illness By M.

After a year of stonewalling by the DOD, a new study at the prestigious Tulane

University Medical School confirms that victims of a mysterious sickness may

have been poisoned.

It started with a telephone call nearly two years ago, a call with a question

not yet fully answered: How did antibodies to a chemical compound called

squalene get into the bloodstreams of sick soldiers who served overseas during

the Persian Gulf War, and even of some whose service during that era never took

them outside of the United States?

.. . . . The sick soldiers had one thing in common -- they all had received a

full complement of military immunizations. And with that in mind, laboratories

contacted by Insight began searching for allied clues related to the so-called

Gulf War Syndrome.

.. . . . Now, after nearly 18 months of intensive study, checking and rechecking

related data, the prestigious Tulane University Medical Center School of

Medicine's department of microbiology and immunology, in New Orleans, has

confirmed test results first reported by this magazine a year ago.

.. . . . According to Tulane, antibodies to squalene indeed do appear in the

bloodstreams of the sick veterans -- in fact, the sicker the veteran, the higher

the level of such antibodies.

.. . . . Tulane's final laboratory results are highly significant. Although

squalene is a naturally occurring substance in the human body, associated with

cholesterol, the presence of the antibodies strongly suggests that an outside

antigen -- or medical cause -- is involved here. When Insight first reported the

presence of the squalene antibodies, the Defense Department resisted the

findings, suggesting that some human condition gone awry might explain them.

Certainly that speculation no longer will do.

.. . . . " Yes, it's pretty significant, " says B. , president of

Autoimmune Technologies, LLC, a medical marketing and research firm in New

Orleans hired by Tulane to publicize and market its groundbreaking research into

squalene antibodies. " We're not saying we know how [the antibodies] got there

[in the sick soldiers], but we are saying we have proof positive of an objective

marker that they do exist. "

.. . . . Garry, the widely respected lead scientist at Tulane's department

of microbiology and immunology, whose peer-reviewed medical experiments led to

the assay that confirms the presence of squalene antibodies, modestly describes

his findings to Insight as important. " We can say for certain now that these

antibodies do exist in sick soldiers we've tested, " Garry says.

.. . . . " How this plays into the illnesses of these patients will require more

work, but certainly this is an important marker to begin conducting research, "

he adds. " We're not saying we know how or what caused the antibodies to appear,

but we now can confirm they do exist and that further testing certainly is in

order to find out why, because it would be extremely remote that such antibodies

would appear as a result of natural causes. "

.. . . . Put another way, according to , himself a Ph.D. in cellular

microbiology, it is unlikely these antibodies to squalene resulted from a

naturally occurring cellular dysfunction in the human body. " The objective

marker Tulane has discovered suggests other causes, " says. " It suggests

they were induced from an outside source. "

.. . . . And so the mystery deepens. From the beginning of Insight's

investigation, the DOD has mustered statements from Secretary of Defense

Cohen down to the various surgeons general of the armed forces and the Veterans

Administration and Walter Army Medical Center denying any knowledge, let

alone responsibility, for this presence of squalene antibodies. One reason for

the nervousness at the Pentagon, as congressional investigators and top military

brass privately have told this magazine, is that any linkage between the DOD and

the discovery of the antibodies could suggest that some experimental vaccine was

given to soldiers just before the war began in 1991.

.. . . . Although the DOD vehemently denied it ever had used anything other than

alum-based immunizations on American troops, Insight learned 18 months ago that

in fact DOD medical experts had been working secretly for several years

developing an alternative and more powerful substance to help make certain

immunizing drugs work more effectively and faster. Such compounds are called

adjuvants. Because these compounds can so powerfully affect the body, alum is

the only U.S.-approved adjuvant for humans.

.. . . . However, in the experimental fields of medicine, cutting-edge

biochemical therapies are worked on every day, including alternative adjuvants

to alum. Their use on humans is strictly controlled and only permitted with

government approval in advanced scientific research. Squalene is one such

experimental adjuvant. A powerful immune stimulant, it has been tested at Walter

and the National Institutes of Health for treatment of herpes, malaria and

AIDS.

.. . . . Indeed, Walter not only is the only known U.S. government

manufacturer of squalene, but it has been using squalene in secret anti-HIV

tests in Thailand for a number of years. Yet when Insight first began probing

squalene antibodies as a possible cause for some of the gulf-war sicknesses, the

DOD and Walter denied ever using squalene. They denied even knowing that

such an adjuvant existed or that it was one of a series of high-tech

experimental " medicines " undergoing tests by the military. Only after this

magazine reported the preliminary test results on the sick vets -- without

identifying the role of Tulane's medical laboratory -- did the DOD finally

acknowledge its experiments with squalene. But for two years DOD officials

steadfastly have denied that they ever administered any secret vaccines to

gulf-war soldiers or that they administered anything not approved by the Food

and Drug Administration, or FDA.

.. . . . Despite repeated requests from this magazine and from interested

lawmakers, DOD officials also have refused on the record so much as to

investigate whether squalene antibodies have in fact been found in the sick

soldiers. The response has been: We never used it, it's only a theory -- and

therefore we don't need to pursue it. Moreover, DOD officials have waged a major

behind-the-scenes campaign for the better part of a year to try to discredit

Insight's initial reports about these matters. " They came in and briefed us and

told us your story was full of shit, " said a senior aide on the House Veterans'

Affairs Committee. Rep. Shays, a Connecticut Republican who chairs the

Government Reform and Oversight subcommittee on Human Resources, says that when

he tried to look into the issue he was assured there was nothing to it.

.. . . . Shays and members of the Veterans' Affairs and Armed Services committees

who had promised to pursue the mystery of the squalene antibodies all ran into

the DOD's disinformation campaign. Also, the initial test results Insight

reported were just that. Without a peer-reviewed paper in a scientific journal

to confirm details or the name of the laboratory conducting the research, the

DOD flacks managed to stonewall and cast doubt on the story.

.. . . . Another and equally important reason the issue was dropped, according to

congressional and DOD officials, was a campaign directed at a Tennessee

immunologist named Pamela Asa. She was the first to advance the theory that one

of the causes of so many unexplained illnesses in gulf-war vets might be an

autoimmune dysfunction caused by immunizations. Because she is not a nationally

renowned scientist like Garry, it was suggested that she could not be taken

seriously by DOD and her theory was bunk. Behind the scenes, DOD secretly

commissioned a " study " three years ago that, according to a high-level DOD

medical scientist, was designed to bury the Asa theory when she became " a pain

in our butt, calling around and causing trouble. " That " study " lay dormant until

Insight broke the initial squalene story. DOD officials then trotted it out as

" proof " that not only was her theory wacky but there was no medical basis for

claims that an " unknown adjuvant " might be one of the causes of so

much sickness.

.. . . . Contrary to the odd picture painted by the DOD, however, the Pentagon

never did an exhaustive study on whether an experimental squalene adjuvant was

used on soldiers, let alone the theory of adjuvants' disease. What DOD

commissioned was a study concerning the plausibility of the theory that

adjuvants could have had any role in making so many soldiers sick. Since the

study's authors were told that only alum was used, the research paper concluded

that Asa's theory was not plausible.

.. . . . The DOD even put out press releases and Internet messages arguing that

because it never used squalene in any immunizations during the Persian Gulf War,

the Insight story must have been based on bogus test procedures that simply

picked up molecular traces of the naturally occurring squalene.

.. . . . Meanwhile, in the intervening year, Tulane's Garry and his team quietly

continued to perfect their testing protocol and systematically eliminated

possibilities put forth by DOD. Scientific literature reviewed shows that

squalene could not be absorbed orally or topically. And Tulane determined that

production of antibodies to a naturally occurring substance in the human body

would be remote, if not virtually impossible.

.. . . . " I think you would discover that life exists on Mars before you could

believe these [antibodies] were naturally occurring, " says Garry. " My God, the

human body is a very tough customer from a cellular biological perspective. Even

people who were exposed to radiation from World War II did not show basic

changes in their molecular biology. "

.. . . . Rep. Jack Metcalf, a Washington Republican, dissatisfied with the shaky

DOD responses, called on the General Accounting Office for an investigation. The

yearlong GAO probe, though still confidential, has not found evidence that the

DOD used squalene in immunizations given to gulf-war troops. But its

investigators are troubled by the confusing and incomplete facts offered by DOD

concerning the now-undeniable presence of squalene antibodies. In the

as-yet-unpublished report, the GAO has recommended that Congress conduct

hearings.

.. . . . " The responses and documents obtained by GAO closely tracked what you at

Insight got, " says one of more than two dozen sources familiar with both the GAO

probe and the medical tests conducted by Tulane's medical department. " First the

DOD said they didn't have [squalene]; then they said they did but never used it;

then they said they used it but only after the war; then they admitted they had

manufactured it prior to the war but claimed they never used it; then it was

confirmed that it has been used overseas in trials for a number of years; then,

well, you get the picture, " says one of these Insight sources.

.. . . . Tulane's confirmation contains immense implications, according to

several DOD, congressional and government scientists. " What this tells us is

that something containing squalene was exposed to these patients, " says Asa, who

long has suspected that with good intentions but disastrous results the military

administered an unknown experimental vaccine just prior to the Persian Gulf War.

.. . . . No evidence yet has surfaced to confirm this scenario, say those who

have investigated the mystery of the squalene antibodies. And a highly sensitive

DOD often makes this point in response to media inquiries. However, based partly

on the medical tests and partly on DOD's contradictory responses concerning

squalene's uses in experimental sciences, a number of medical, military,

laboratory and veterans groups now are skeptical -- and nervous -- about the

possibility that something that went awry is being hidden.

.. . . . Veterans' fears are not being assuaged by DOD's refusal to release

records involving its experiments with squalene -- nor is there comfort in its

refusal to release details of what its various vaccines during the gulf war

contained. The FDA, reportedly at the request of DOD, has declined to provide

any information whatsoever related to those vaccines -- even to the GAO.

.. . . . " They have created an air of mystery by their actions that has certainly

raised suspicions, " a government official says. " Even if they are innocent, they

have acted so guilty as to raise questions. It would be such a simple thing to

just go and test for these antibodies. " Indeed, to Garry, Asa and hundreds of

gulf-war vets who have volunteered for strict double- and triple-blind tests for

squalene antibodies as administered by Tulane's Medical School, these actions by

the military are deeply troubling. " I don't understand their position, "

confesses Garry, who often has worked with DOD and other government agencies.

" They could have taken our testing protocol and quickly determined if there was

any validity to the allegation. "

.. . . . Many of the DOD officials interviewed by Insight, as well as those

interviewed by the GAO, have gone to extraordinary lengths to distance the

Pentagon from the issue of the squalene antibodies. One reason advanced by many

of the veterans and their families may have to do with the way several hundred

of the sick soldiers were treated immediately after the gulf war and ever since.

Scores of them were placed in Walter 's special HIV ward and isolated even

from their doctors by personnel brought in from special DOD units to conduct

medical evaluations based on AIDS-related symptoms. Many of these patients not

only never learned what the specialist teams discovered, or for that matter what

they failed to find, but they were required to submit to further semiannual

HIV-examination testing procedures for many years without explanation.

.. . . . Metcalf says the reasons behind any stonewalling are not nearly so

important as getting help to thousands of sick gulf-war soldiers. " I have been

deeply concerned about this issue since it was first brought to my attention by

veterans suffering from gulf-war illnesses, " he says in a statement prepared for

Insight. " They had read the news reports about blood samples of some Gulf

War-era veterans containing antibodies to squalene. They want to know the truth

about why they are sick. "

.. . . . Metcalf continues, " I believe that any legitimate research that could

provide clues as to the nature and treatment of their illnesses must be pursued

vigorously. I asked the GAO to look into the issue ... and to determine if there

was any possibility that veterans had received squalene and to determine if the

reported research was valid. "

.. . . . The magnitude of the problem is considerable. " With over 100,000 of our

veterans suffering, the DOD history of foot-dragging and obfuscation on this

issue is inexcusable, " Metcalf says. " The GAO study tells us that we can spend

just a few thousand dollars and possibly unravel the mystery of gulf-war

illnesses. We have a moral obligation to stand with the honorable men and women

who sacrificed for this nation in their search for effective treatment ... and I

demand DOD act on the GAO recommendations. " Calls to DOD for official comment

were not returned.

.. . . .

Anatomy of a Discovery: Leading University Confirms Suspicions

.. . . . It was nearly seven years ago. By a quirk of fate, a shipping label

accidentally was left on a batch of test tubes containing blood specimens taken

from sick vets. The squalene mystery began to unfold.

.. . . . At the time, U.S. soldiers returning home were complaining about strange

illnesses. Defense Department and Veterans Administration officials said there

were no medical reasons for their sickness. No chemical or biological weapons

had been used in theater, nor were there nuclear-related reasons. But more and

more veterans, initially those who served overseas and then those who never left

the United States, complained of autoimmune ailments that had no known cause.

And more and more the soldiers were told their illnesses were psychological or

possibly related to a combination of desert heat and allergy to insecticides --

and not to worry. What was occurring behind the scenes, however, told another

story, according to a two-year investigation by Insight into the discovery of

antibodies to squalene in the blood of the sick.

.. . . . As it worked feverishly in public to deny any link between the odd

illnesses and symptoms reported by a growing number of soldiers who served

during the gulf war, medical personnel inside the military and the VA were

working quietly to determine whether something indeed was causing gulf-era

soldiers to fall ill and, in a growing number of cases, to die for unexplained

reasons.

.. . . . While the Pentagon denied that a secret arsenal had been unleashed by

Iraq on U.S. forces in theater, Walter Army Medical Center was working on a

variety of theories involving possible biological or chemical weaponry.

.. . . . In one of many experiments -- conducted without the knowledge of

soldiers, family and (in many cases) even the patient's doctors -- teams of

medical specialists secretly obtained blood samples of sick veterans. In one

case, blood collected from sick gulf-war soldiers was shipped to s Hopkins

University in Baltimore, where specialists in environmental sciences were asked

to determine if anything unusual could be detected in the samples. At the

request of a doctor at Walter who worked in the HIV experimental-sciences

section, s Hopkins was asked to conduct unusual but very specific tests for

an autoimmune disease -- notwithstanding that the DOD had denied it was

searching for such a cause.

.. . . . Enter Tulane University Medical School and Dr. Garry. Unable to

conduct the specialized tests requested, s Hopkins made arrangements with

Garry, a noted retrovirologist, to test for HIAP (Human Intracisternal A-type

Retroviral Particle), a medical marker associated with autoimmune diseases

believed to be linked with HIV, the AIDS precursor. To conduct such tests,

Tulane was sent blood samples drawn from sick vets. Garry initially believed

these came from s Hopkins. It was not for several years, when checking a

saved shipping label to answer a reporter's questions, that Garry and Tulane

realized the blood samples had come via Hopkins from the Walter physician

who worked on HIV.

.. . . . Garry examined the blood and reported negative findings to s Hopkins

-- which, in turn, so informed Walter . When he had finished his research

for s Hopkins in the early 1990s, Garry called to determine what to do with

the blood samples still on hand. He was told to do whatever he cared to: Since

the tests were negative, s Hopkins said that neither it nor its client

needed them returned.

.. . . . Unknown to s Hopkins, as well as Walter , Garry's laboratory

froze the samples and locked them away until 1997, when Pamela Asa began looking

for clues about the possible causes of Gulf War Syndrome. She had theorized that

an unrevealed vaccine or vaccine component such as an adjuvant might be

contributing to the illnesses reported by sick soldiers.

.. . . . Over many months of testing, Asa zeroed in on squalene as an

experimental adjuvant that the military might have used to protect soldiers from

biological- or chemical-warfare agents. Knowing of Garry's work in the polymer

sciences, she contacted the Tulane expert and they began a loose collaboration,

sharing information and conducting tests on patients to search for clues.

.. . . . When Insight began investigating Asa's theory of possible

squalene-related causes, Garry had just begun working on a protocol test based

on blood he obtained from sick soldiers. Remembering he had received similar

samples a few years earlier via s Hopkins, he also started testing the older

samples. It was then that the antibodies to squalene began to be detected --

Asa's theory was beginning to show promise.

.. . . . Tracking doctors involved in experimental medicine at Walter ,

Insight came across the name of the military doctor mentioned by chance to

Garry, who remembered the same doctor had shipped the s Hopkins blood

samples to him. When the original shipping labels and medical-test orders were

reviewed -- like the blood samples, the meticulous Garry had saved the shipping

labels and instructions -- Garry's memory was confirmed: It was the same doctor,

a medical specialist at Walter 's advanced-sciences section, who had been

working for years on experimental AIDS vaccines in Thailand using squalene as a

possible adjuvant. Further checks of confidential military records also

confirmed that Walter was the only known manufacturer of this experimental

substance on record.

.. . . . Working with his forgotten but now invaluable consignment of early vet

blood samples supplied by s Hopkins via Walter , Garry and his team at

Tulane went forward with their protocol to search for squalene. After months of

testing using both natural and synthetic forms of the adjuvant, the protocol

confirmed the presence of squalene antibodies in the blood of only the sick

soldiers -- both those who served overseas and also sick veterans who served

during the era but never got to the Middle East. The only link was that all got

their full complement of immunizations.

.. . . . Along the road to discovery, however, there were some bumps. At one

point the Garry tests did not detect naturally produced squalene, only the

synthetic form. This seemed odd and was pounced upon by DOD officials when

Insight reported the initial test results. Over time, however, Garry realized

that, unless it is very fresh, naturally occurring squalene will begin to break

down at a molecular level. With fresh supplies of naturally occurring squalene

on hand, the tests still came back positive, just as they had (and should have)

with the synthetic squalene samples.

.. . . . Garry began to refine his protocol and continued testing until both he

and Tulane, along with Asa and her laboratories, were confident of the testing

procedures and results. Because of the importance of the study, Tulane and Garry

agreed to file a patent jointly with Asa and to submit their findings separately

to peer-reviewed medical/science journals.

.. . . . Once all these elements were put together, Insight was released from its

pledge of confidentiality. In the next few days, supported by the General

Accounting Office's separate investigation and the soon-to-be published results

of the laboratory findings reported here, Washington Republican Rep. Jack

Metcalf will be asking for full-blown hearings by the House Veterans' Affairs

and Armed Services committees.

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ROBERT F. GARRY ( TULANE UNIVERSITY ) ON THE RECORD

STATEMENT FOR HEARING RECORD

The House Subcommittee on National Security, Veterans Affairs,

and International Relations

January 24, 2002

Submitted by:

F. Garry, Ph.D., Professor

Department of Microbiology and Immunology

Tulane Medical School, Room 568 JBJ

1430 Tulane Avenue

New Orleans, Louisiana 70112

SUMMARY

This Statement concerns our research with anti-squalene antibodies, including

the discovery of these antibodies in the blood of patients with Gulf War

illness. Our published data and additional data which has been accepted for

publication strongly suggests that Gulf War illness is closely associated with

an abnormal immune response to squalene indicated by the presence of these

antibodies.

Our research also links specific lots of anthrax vaccine known to contain

squalene to the production of anti-squalene antibodies. In addition, our

research demonstrates that the blood test for detecting these antibodies, the

anti-squalene antibody assay, may be an excellent tool to aid in the diagnosis

of Gulf War illness.

U.S. Army researchers have verified our discovery of the antibodies and, in May

of this year, submitted a patent application covering their anti-squalene

antibody work. Our patent, U.S. Patent No. 6,214,566, " Method for Detecting

Anti-Squalene Antibodies, " which we believe covers the same technology, had

already issued in April of this year. The Army researchers have made a

disingenuous attempt to discredit our work, and they have not yet published any

studies designed to confirm our discovery of a link between the antibodies and

Gulf War illness, though they state that such studies may be feasible.

We believe that such confirmatory studies and additional studies should be

undertaken without delay. We also believe that the anti-squalene antibody assay

should immediately be made available under government sponsorship to all

physicians interested in using it to investigate the condition of their Gulf War

illness patients.

DATA AND OBSERVATIONS

Research data which we published in February 2000 strongly suggests that

anti-squalene antibodies are closely associated with Gulf War illness.

Specifically, we found in our study participants that 95% of the Gulf War

veterans with Gulf War illness and 100% of the non- deployed veterans with Gulf

War illness were positive for the presence of anti-squalene antibodies, while 0%

of the healthy deployed veterans were positive. Additional research data which

has now been accepted for publication shows, in a limited number of samples

tested, that an increased prevalence of anti-squalene antibodies in Anthrax

Vaccine Immunization Program (AVIP) personnel correlated with administration of

lots of anthrax vaccine subsequently shown by the FDA to contain trace amounts

of squalene. Our results strongly suggest that the production of anti-squalene

antibodies is linked to symptoms of Gulf War illness and to the presence of

squalene found in certain lots of anthrax vaccine.

Though the source of the squalene in the vaccine lots has not, to my knowledge,

been identified, squalene is used as an adjuvant in animal vaccines. The use of

squalene as an adjuvant in human vaccines has not been approved, and human

exposure to squalene in vaccines has been shown by others to cause immunological

symptoms similar to those found in Gulf War illness patients.

Gulf War illness is present both in Gulf War veterans who were deployed to the

Persian Gulf War theater of operations and in personnel who were not deployed,

including personnel who never left the United States. The absence of an

association between the presence of Gulf War illness and deployment indicates

that the causative agent or factor is not associated with the Persian Gulf.

Consistent with this observation are the results of a recent epidemiological

study finding that vaccinations that were given to both deployed and

non-deployed personnel are associated with ill health.

U.S. Army researchers have confirmed our discovery that anti-squalene antibodies

do exist and can reliably be detected, and the Army researchers published this

work in November 2000. Army representatives filed a U.S. patent application

covering anti-squalene antibody technology on May 18, 2001, and we believe that

the technology for which the patent was filed is the same technology that was

described in the November 2000 article.

A U.S. patent covering our anti-squalene antibody technology issued as of April

10, 2001. The patent is assigned to Tulane University and is licensed to a New

Orleans biomedical company. We believe that the claims awarded in the Tulane

patent cover the work that was published by the Army researchers. On May 23,

2001, Tulane's licensee wrote a letter to the Department of Defense offering to

sublicense this patented technology to the Army so that the Army researchers

could perform a study designed to confirm whether the antibodies are linked to

Gulf War illness. An Army representative declined this offer on June 6, 2001.

The journal that published the November 2000 article by the Army researchers

received the submitted article on April 18, 2000. The material submitted to the

journal on that date demonstrated that the Army researchers had confirmed our

discovery of anti-squalene antibodies. In June 2000, one of these same

researchers, an Army colonel, published a letter to the editor of the journal

which had published our original article in February 2000. In the June 2000

letter, the colonel stated that our published results constituted a " new,

unproven assay that claims to detect a novel antibody. " The colonel made this

statement despite the fact that he had already confirmed our discovery and had

already submitted his findings for publication. Further, when the colonel's

article appeared in November 2000, it cited his own letter of June 2000 to call

our original findings into question. The colonel's letter expressing an opinion

which he himself had already proven to be baseless was thus used twice

in efforts to discredit our work.

The last paragraph of the November 2000 article published by the Army

researchers reads as follows:

" With the development of the ELISA using PVDF membranes, as described in this

paper, it may now be possible to undertake studies with serum from sick and

healthy individuals to determine whether naturally-occurring antibodies to SQE

[squalene] exist, and whether the appearance or amounts of such antibodies have

any relationship to normal physiologic functions or whether they are associated

with any illness. "

With the serum samples available to the Army researchers, such studies would in

our opinion be very straightforward and would take a short amount of time to

complete. The Army has had its own version of the necessary test available for

more than two years but has published no such studies.

Based on the Army's actions with respect to our work, we suspect that the Army

has in fact conducted these studies and elected not to publish them. Our

published research makes a compelling case that, first, anti-squalene antibodies

exist, and second, that there is a link between the antibodies and Gulf War

illness. Before the publication date of our research, some of our research data

was discussed in a GAO report to the Honorable Jack Metcalf entitled Gulf War

Illnesses: Questions about the Presence of Anti-Squalene Antibodies Can Be

Resolved (GAO/NSIAD-99-5, March 1999). The GAO report specifically recommended

that the DoD conduct its own research designed to replicate or dispute our

results. The colonel's research group subsequently published a confirmatory

study that looked only at our first finding and ignored the second. A

confirmatory study of our second finding would be very easy for the Army to do

in a short time, and we find it difficult to believe that the colonel's group

has not already done such a study, since any good and inquisitive scientist

with ready access to test samples would want to do it. Instead of following the

GAO's recommendation, however, the colonel chose to publicly ignore our second

finding and to make misleading public statements that denigrated our work.

Later, when the Army and the colonel were offered the opportunity to license our

technology and finish the confirmatory work, they declined the offer.

The presence of anti-squalene antibodies in ill people and the absence of the

antibodies in healthy people is the first hard laboratory evidence that Gulf War

illness is what some might refer to as a " real disease. " It is also the first

evidence that an abnormal immunological response is under way in Gulf War

illness patients. The anti-squalene antibody assay thus represents the first

laboratory test for Gulf War illness. As such we believe that it has great

clinical value as a diagnostic aid, and it suggests that therapies designed to

modulate the immune response to antigens should be investigated in patients with

Gulf War illness.

Recent unpublished observations from the Veterans Administration indicate that

there is a significant increase in the prevalence of the neuro-degenerative

disease amyotrophic lateral sclerosis (ALS) in Gulf War veterans. The data that

we published in February 2000 shows that some of the patients who were ill with

Gulf War illness and who tested positive on the anti-squalene antibody assay

exhibited neurological symptoms. These results suggest that a possible

relationship between anti-squalene antibodies and ALS in Gulf War veterans may

exist and should be investigated.

Further research with the anti-squalene antibody assay continues on a limited

scale using private funds, but the test is not currently available to individual

physicians for investigation into the conditions of their patients. More than

two years have now elapsed since DoD researchers have had access to a version of

this test. While the DoD has proceeded with an attempt to win its own patent on

the test, in our opinion it has done nothing with the test to help any Gulf War

illness patient. It is therefore our very strong recommendation that an agency

of the U.S. government immediately commission a large study of anti-squalene

antibodies and Gulf War era veterans and other personnel, including appropriate

ALS patients. Such an investigation should be conducted in the context of, or

coordinated with, a population-based study of Gulf War era veterans similar to

the ongoing and successful Ranch Hand study of Agent Orange. It is our further

very strong recommendation that an agency of the

U.S. government immediately begin to provide the anti-squalene antibody assay

to all physicians treating patients with Gulf War illness.

REFERENCE INFORMATION

(1) Our initial study concerning anti-squalene antibodies was published in the

February 2000 issue of Experimental and Molecular Pathology. The results of this

study strongly suggest two things: (1) that humans can indeed raise serum

antibodies against squalene, and (2) that, in the people studied, the presence

of the antibodies correlated very closely with the presence of the symptoms of

Gulf War illness both in personnel who had been deployed to the Persian Gulf

theater and in personnel who had not been deployed there. A copy of this

article, entitled " Antibodies to Squalene in Gulf War Syndrome, " is attached

hereto ( " the Asa/Garry article " ).

(2) The anthrax bacillus is incapable of producing squalene, and squalene is not

present as a constituent of the growth medium used to produce the organism for

the anthrax vaccine. Squalene is widely used as a vaccine adjuvant in animals,

but it is clearly harmful to many humans when used in that manner and is not

approved for use in human vaccines.

(3) A letter to the editor published in the June 2000 issue of Experimental and

Molecular Pathology addresses the work presented in the Asa/Garry article. The

letter attempts to find fault with our testing technique, calling our test a

" ... new, unproven assay that claims to detect a novel antibody .... " The letter

further states the following:

" The conclusions of Asa and colleagues, purporting to correlate anti-squalene

[sic] with Gulf War illnesses, in our opinion, rely on circular logic. Positive

results with an assay not previously validated cannot be used as scientific

proof that antibodies to the antigen exist in samples of unknowns. It is

premature to proceed directly to testing serum samples from healthy people and

sick people before conducting the fundamental validation steps. "

This letter was written by Col. Carl Alving of the Walter Army Institute of

Research and Grabenstein of the U.S. Army Medical Command. A copy of this

letter ( " the Alving/Grabenstein letter " ), together with our published response

and an editorial note, is attached hereto.

(4) In the November 2000 issue of the Journal of Immunological Methods, four

researchers from the Walter Army Institute of Research, including Col.

Alving, published an article confirming that anti-squalene antibodies do exist

and can reliably be detected. The study described in this article reproduces and

expands upon our work and validates our anti-squalene antibody assay. A copy of

this article, entitled " Induction and Detection of Antibodies to Squalene, " is

attached hereto ( " the Alving article " ).

(5) A notation by the Journal of Immunological Methods which appears under the

title line at the top of the Alving article states that the manuscript for the

article was received by the journal from Col. Alving and his colleagues on 18

April 2000. The Alving/Grabenstein letter was published six weeks later, in June

2000. This means that when Col. Alving and his colleague Grabenstein were

publicly characterizing our test as a " ... new, unproven assay that claims to

detect a novel antibody ..., " Col. Alving and his other colleagues had already

written the Alving article confirming that the new antibodies did in fact exist.

(6) The note from the journal's editors which accompanies the Alving/Grabenstein

letter points out that this letter

" ... relates to methodology. Drs. Alving and Grabenstein offer no data against

the conclusions of Asa et al. "

Since the Alving article confirms that the novel antibody was indeed discovered

by our detection method, the Alving/Grabenstein letter is therefore rendered

entirely meaningless by the Alving article. Despite this, the Alving article

includes the following paragraph:

" What, if any are the potential consequences of induction of antibodies to SQE

[squalene]? A recent publication claims to have detected antibodies to SQE in

sick but not in healthy individuals (Asa et al., 2000) [the Asa/Garry article].

However, we believe that such a conclusion may be premature, based on a

technical critique of the reported Western blot-type assay that was used (Alving

and Grabenstein, 2000) [the Alving/Grabenstein letter]. "

The Alving article thus cites the Alving/Grabenstein letter, which the Alving

article itself refutes, to call into question our second discovery, that the

anti-squalene antibodies we discovered are found in sick but not healthy

individuals.

(7) After the Asa/Garry article was published, we learned that in June 1999,

investigators at the U.S. Food and Drug Administration (FDA) had assayed the

Department of Defense's anthrax vaccine for the presence of squalene. Using a

sensitive gas-liquid chromatography procedure, the FDA had identified squalene

in certain lot numbers (FAV 020, 030, 038, 043 and 047) of the vaccine. Although

the amounts of squalene found in these lots of the vaccine by the FDA were small

(parts per billion), in principle even these small amounts may have been

sufficient to induce in some vaccine recipients the immune response that is now

being manifested by the presence of anti-squalene antibodies. The published work

of other researchers has strongly linked exposure to the anthrax vaccine and

other vaccines to the development of Gulf War illnesses. Moreover, many

pathological effects of exposure to squalene-containing vaccine adjuvants are

well known to rheumatologists, and a number of these pathologies

bear striking similarity to the signs and symptoms displayed by some ill Gulf

War era veterans.

(8) On April 10, 2001, U.S. Patent No. 6,214,566, " Method for Detecting

Anti-Squalene Antibodies, " was awarded and assigned to Tulane University. A copy

of this patent is attached. Tulane has licensed the anti-squalene antibody

technology to Autoimmune Technologies, LLC of New Orleans. On May 23, 2001, the

LLC Manager of that firm wrote a letter to The Secretary of Defense with a copy

to Col. Alving offering to sublicense the patented technology to Department of

Defense researchers. On June 6, 2001, an intellectual property counsel of the

Army wrote back to decline the offer. Copies of both the May 23rd and the June

6th letters are attached.

(9) On October 22, 2001, in accordance with 37 CFR 404.6, the Department of the

Army filed a notice of the " Availability for Non-Exclusive, Exclusive, or

Partially Exclusive Licensing of U.S. Patent Application No. 09/859,389 entitled

'Detection of Antibodies to Squalene in Serum' filed May 18, 2001. " On November

8, 2001, the LLC Manager of Autoimmune Technologies spoke on the telephone with

the patent attorney and the licensing officer at Fort Detrick who were

administering this license. Neither the attorney nor the licensing officer was

aware of the existence of U.S. Patent No. 6,214,566, and neither person knew

whether U.S. Patent Application No. 09/859,389 was based upon the work done by

Col. Alving and his colleagues. The LLC Manager pointed out to both of them

that, in our opinion, the work done and published by Col. Alving's group is

covered by the claims awarded in U.S. Patent No. 6,214,566. The LLC Manager also

asked for further information about the technology which the

Army was proposing to license. As of December 18, 2001, the LLC Manager had not

received this additional information, and he wrote a letter on that date to both

the attorney and the licensing officer. A copy of that letter is attached.

# # #

Return to Witness Testimony List | Return to VetCenter's Main Lobby

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ANTI-SQUALENE ANTIBODIES

LINK GULF WAR SYNDROME TO ANTHRAX VACCINE

Data published in the February 2000 and August 2002 issues of Experimental and

Molecular Pathology strongly suggests that Gulf War Syndrome is caused by a

vaccine contaminated with squalene.

The August 2002 article is entitled " Antibodies to Squalene in Recipients of

Anthrax Vaccine " (Exp. Mol. Pathol. 73,19-27 (2002)).

Gulf War Syndrome, or GWS, is the term which has been applied to the

multi-symptom rheumatic disorder experienced by many veterans of the 1990-1991

Persian Gulf war. A similar disorder appeared in 1990-1991-era personnel who

were never deployed to the Persian Gulf theater of operations and also in other

military personnel, including participants in the Anthrax Vaccine Immunization

Program, or AVIP, which was inaugurated in 1997. No data has ever suggested that

the disorder experienced by the deployed 1990-1991 soldiers is different from

the disorder experienced by the other groups of patients, but the other cases

have not been considered to be cases of GWS.

Squalene was found by the U.S. Food and Drug Administration in five lots of the

AVIP anthrax vaccine. The discovery of serum anti-squalene antibodies and the

development of a test to detect these antibodies has made it possible to see

that links appear to exist between the contaminated AVIP vaccine lots, the

illness experienced by post-1997 vaccine recipients, the illness experienced by

non-deployed 1990-1991-era patients, and the illness in deployed 1990-1991-era

patients that has been referred to as GWS.

The data establishing these links is presented in the peer-reviewed February

2000 and August 2002 articles. The published findings (1) strongly suggest that

the GWS-like illness being reported by all of the various patient groups is the

same illness, (2) strongly suggest that the contaminated vaccine caused the

illness in the AVIP group, and (3) further suggest that squalene contamination

of one or more 1990-1991-era vaccines accounts for the GWS cases from that era.

Before the anti-squalene antibody test was developed, there was no specific

laboratory test for GWS. Both articles suggest that the antibodies can serve as

an excellent laboratory marker to help identify patients with GWS. Using the

antibodies as a laboratory marker for GWS could be very useful in helping

physicians diagnose the disorder and in differentiating it from other rheumatic

illnesses.

Anti-squalene antibodies might also provide a key to more effectively treating

GWS patients. The presence of the antibodies in GWS patients indicates that the

immune system is involved in the development of GWS. Effective drugs which

modulate the human immune system are already in wide use, but they have not been

previously considered to be appropriate for GWS patients. The published data now

suggests that the use of immune modulators in GWS patients should be studied.

A detailed discussion of the data in the February 2000 and August 2002 articles

can be found in the Autoimmune Technologies news release dated July 15, 2002.

Further information about the discovery of squalene in the AVIP vaccine lots can

be found in the statement made by former U.S. Congressman Jack Metcalf on

September 27, 2000 to the House Subcommittee on National Security, Veterans

Affairs, and International Relations.

In March 1999, the United States General Accounting Office (the GAO) encouraged

the Department of Defense to investigate the discovery of anti-squalene

antibodies. In GAO/NSIAD-99-5, " Gulf War Illnesses - Questions About the

Presence of Squalene Antibodies in Veterans Can Be Resolved, " the GAO urged the

DoD to conduct its own research into anti-squalene antibodies with two

objectives in mind: (1) to confirm the existence of the newly-discovered

antibodies, and (2) to acquire patient data, explore the apparent link between

the antibodies and the illness in GWS patients, and attempt to confirm or

disprove the existence of such a link. Click on GAO/NSIAD-99-5 for a PDF version

of this report. See Notes on PDF Files if you would like help with the PDF

format.

To satisfy the first GAO objective, the Army researchers confirmed that

anti-squalene antibodies do indeed exist and can reliably be detected. They

published their findings in an article entitled " Induction and Detection of

Antibodies to Squalene, " which appeared in the November 2000 issue of the

Journal of Immunological Methods (J Immunol Methods 2000 Nov 1;245(1-2):1-14).

The Army researchers conducted their testing by applying squalene to the wells

of ELISA plates. Dr. F. Garry, the Tulane Medical School professor who

discovered anti-squalene antibodies and developed the test for detecting them,

and his colleagues conducted their testing for the February 2000 and August 2002

articles by applying squalene to nitrocellulose strips in a Western-blot-type

assay. There is no material difference between the two test methods, and both

are covered by the patent which subsequently issued to Tulane.

Although the Army researchers confirmed the validity of the test and thus added

support to the February 2000 patient data, their November 2000 article included

no patient data of its own and as a result did not specifically address the

GAO's second objective. The Army researchers also failed to embrace the

peer-reviewed February 2000 data itself, as is discussed in the statement

submitted by Dr. Garry to the House Subcommittee on National Security, Veterans

Affairs and International Relations for the record of its hearing into Gulf War

illnesses on January 24, 2002. Dr. Garry's statement can be seen on the

Subcommittee's Web site at

http://www.house.gov/reform/ns/statements_witness/garry_jan_24.htm and on the

Autoimmune Technologies Web site at Garry 24 Jan 2002 House Subcommittee

Statement.

Tulane has licensed the anti-squalene antibody technology to Autoimmune

Technologies. U.S. Patent No. 6,214,566 covering the anti-squalene antibody

test, which the Company calls the Anti-Squalene Antibody Assay or ASA Assay, was

awarded to Tulane in April 2001. Because this patent covers the method which was

used by the Army researchers to verify the existence of the antibodies,

Autoimmune Technologies has offered the ASA Assay technology to the Department

of Defense for use in conducting a large confirmatory study of the patient data

in the February 2000 and August 2002 articles. The Company has urged the DoD to

sponsor such a study.

For information about the patented Anti-Squalene Antibody Assay, go to the Gulf

War Syndrome Laboratory Test Page.

This material is not intended to take the place of a physician's advice.

See the Autoimmune Technologies GWS News Release dated July 15, 2002

See the Autoimmune Technologies GWS News Release dated January 31, 2000

Go to the Autoimmune Technologies Home Page

LABORATORY TEST FOR GULF WAR SYNDROME

The Patented Anti-Squalene Antibody Assay, or ASA Assay

The patented Anti-Squalene Antibody Assay, or ASA Assay, is a test that detects

antibodies to squalene in human blood. Peer-reviewed research data that was

obtained by using this test has linked squalene-contaminated lots of the vaccine

used in the DoD's post-1997 Anthrax Vaccine Immunization Program (AVIP) to the

development of anti-squalene antibodies. These antibodies were previously linked

to the multi-symptom rheumatic illness known as Gulf War Syndrome. For more

information about this data and its implications, see the Gulf War Syndrome

Research Page.

U.S. Army researchers duplicated this test, and in November 2000 the Army

researchers published their research confirming the discovery of anti-squalene

antibodies. A patent on the ASA Assay was awarded in April 2001, and Autoimmune

Technologies holds the rights to that patent. The patent covers various methods

for detecting anti-squalene antibodies, including the testing method that was

used by the Army researchers. To enable the DoD to sponsor a large confirmatory

study of the link between squalene contamination in vaccines and GWS, Autoimmune

has offered the patented ASA Assay technology to the Department of Defense and

has strongly urged the DoD to sponsor such a study.

In addition to helping identify patients with GWS, the discovery of

anti-squalene antibodies might also provide a key to more effectively treating

GWS patients. The presence of the antibodies in GWS patients indicates that the

immune system is involved in the development of GWS. Effective drugs which

modulate the human immune system are already in wide use, but they have not been

previously considered to be appropriate for GWS patients. The published data now

suggests that the use of immune modulators in GWS patients should be studied.

Autoimmune Technologies is not currently offering the ASA Assay for

investigation into individual GWS cases, but when the benefits of the test

become clear to all of the groups involved in assessing GWS, Autoimmune will

immediately make the ASA Assay available to interested physicians for

investigational use.

GWS patients or physicians who would like to receive notification when the Assay

does become available for investigational use may send their name, mailing

address, and their physician's name if they are a patient, to GWS@...

via e-mail or to the postal address given in the How to Contact Us page.

IMPORTANT NOTE CONCERNING E-MAIL: Because of the recent proliferation of " spam "

messages, the GWS@... mailbox is now being filtered by subject line.

Please begin the subject line of your e-mail message with the word Test in order

to pass through the filter.

For more information, go to the Gulf War Syndrome Research Page

Go to the Autoimmune Technologies Home Page

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Letter From Sen. ph R. Biden, Sen. R. Carper and Rep. N.

Castle to Sec. Rummsfeld

http://www.delawareonline.com/newsjournal/local/2004/10/15squalene_letter.html

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Letter from 2002 Petitioning against Anthrax Vaccine

From: JH88008@...

Sent: Wednesday, January 02, 2002 10:09 PM

fdadockets@...

Subject: Copy of petition

FDA

cc Congressman Rick Boucher

From C. Hammell, President

International Advocates for Health Freedom

POB 625 Floyd VA 24091

FDA:

In light of the points below, I agree with the Anthrax Vaccine Network

http://www.anthraxvaccine.net/ and totally oppose the Anthrax vaccine. I would

like the FDA to ban this dangerous vaccine and revoke Bioport's license to

manufacture it. It is clearly a very dangerous drug. You cannot legally justify

approving this drug for use by the public, and it is wrong that members of the

military are forced to take it.

I would like to know how you intend to handle this matter, and am forwarding

this to Congressman Rick Boucher, my congressman, as well as to my email

distribution list. I am also posting this letter to you on my website in the

Anti Vaccination section.

I regard you to be terrorists. Many other armed Americans also regard you to be

terrorists. In light of the points below, how can we possibly come to any other

conclusion? If you dispute this information, and feel that it is incorrect in

any particular, I would like to know your specific views on this issue. Any lack

of response on your part will be construed by me to be tacit agreement on your

part that you are indeed terrorists, and that you are on a genocidal mission to

kill as many Americans as you possibly can via this improperly tested, clearly

dangerous vaccine.

1. The vaccine's manufacturer, Bioport of Lansing, Michigan, has never passed an

FDA inspection. Numerous problems include lack of sterility, contamination

problems, quality control problems, lack of consistency in manufacturing,

falsification of the expiration dates on some lots of the vaccine (labels were

switched), and the presence of squalene, an adjuvant which is illegal in the

United

States.

2. Adverse reactions to this vaccine range from 40% in men to 70% in women,

according to an Army study. Yet when the program began the FDA-approved product

label admitted to only a 0.2% adverse reaction rate; now it says 5-35%. Adverse

reactions range from severe bone and joint pain, to loss of vision, severe skin

problems, blackouts and loss of consciousness (crashing from a standing position

leads to other injuries, of course), grand mal seizures, internal organ

problems, ALS, multiple sclerosis -- and death. If this was a civilian vaccine,

it would long ago have been taken off the market.

3. The current vaccine, licensed in 1970, failed to meet federal requirements to

prove efficacy in humans prior to licensure; the required trials to prove safety

were conducted, but were of limited scientific validity. The only trial of an

anthrax vaccine in humans, in the late 1950's, was for a different vaccine and

showed efficacy only for cutaneous, or skin contact. The Dept. of Defense wanted

a vaccine against aerosolized anthrax - that which would be “weaponized” - and

for mass inoculation, and in 1996 submitted to the FDA an Investigational New

Drug (IND) application requesting permission to use it for this purpose. By law

(10 USC 1107), an IND requires informed consent, or a Presidential waiver of

that consent, neither of which currently exist. Absent either, a military order

to take the vaccine is illegal. Yet, if troops refuse the vaccine, they are most

often fined, court-martialed, jailed, and separated from the service under less

than honorable conditions.

4. The General Accounting Office last year (October, 2000) came out with a

report that in the the Air National Guard and Air Force Reserve units that were

required to be vaccinated, 25% of its pilots resign rather than take it.

5. Even if this vaccine were not so dangerous, it may be of limited value in the

short-term. The FDA-approved protocol for taking it calls for three shots each

spaced 2 weeks apart; then three more shots at 6, 12, and 18 months, then annual

boosters for life.

(This is a copy of a petition that I am passing on in support of.)

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Chronic multisymptom illness affecting Air Force veterans of the Gulf War.

Fukuda K, Nisenbaum R, G, WW, Robin L, Washko RM, Noah DL,

Barrett DH, Randall B, Herwaldt BL, Mawle AC, Reeves WC.

Division of Viral and Rickettsial Diseases, National Center for Infectious

Diseases, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.

CONTEXT: Gulf War (GW) veterans report nonspecific symptoms significantly more

often than their nondeployed peers. However, no specific disorder has been

identified, and the etiologic basis and clinical significance of their symptoms

remain unclear. OBJECTIVES: To organize symptoms reported by US Air Force GW

veterans into a case definition, to characterize clinical features, and to

evaluate risk factors. DESIGN: Cross-sectional population survey of individual

characteristics and symptoms and clinical evaluation (including a structured

interview, the Medical Outcomes Study Short Form 36, psychiatric screening,

physical examination, clinical laboratory tests, and serologic assays for

antibodies against viruses, rickettsia, parasites, and bacteria) conducted in

1995. PARTICIPANTS AND SETTING: The cross-sectional questionnaire survey

included 3723 currently active volunteers, irrespective of health status or GW

participation, from 4 air force populations.The cross-sectional clinical

evaluation included 158 GW veterans from one unit, irrespective of health

status. MAIN OUTCOME MEASURES: Symptom-based case definition; case prevalence

rate for GW veterans and nondeployed personnel; clinical and laboratory findings

among veterans who met the case definition. RESULTS: We defined a case as having

1 or more chronic symptoms from at least 2 of 3 categories (fatigue,

mood-cognition, and musculoskeletal). The prevalence of mild-to-moderate and

severe cases was 39% and 6%, respectively, among 1155 GW veterans compared with

14% and 0.7% among 2520 nondeployed personnel. Illness was not associated with

time or place of deployment or with duties during the war. Fifty-nine clinically

evaluated GW veterans (37%) were noncases, 86 (54%) mild-to-moderate cases, and

13 (8%) severe cases. Although no physical examination, laboratory, or serologic

findings identified cases, veterans who met the case definition had

significantly diminished functioning and well-being. CONCLUSIONS:

Among currently active members of 4 Air Force populations, a chronic

multisymptom condition was significantly associated with deployment to the GW.

The condition was not associated with specific GW exposures and also affected

nondeployed personnel.

PMID: 9749480 [PubMed - indexed for MEDLINE]

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******

Prevalence and patterns of Gulf War illness in Kansas veterans: association of

symptoms with characteristics of person, place, and time of military service.

Steele L.

Kansas Commission on Veterans Affairs, Topeka 66603, USA.

kspgwvets@...

Gulf War veterans have reported health problems that they attribute to their

military service, but little is understood about the nature or extent of these

conditions. To determine whether Kansas Gulf War veterans are affected by excess

health problems, a population-based survey of 1,548 veterans who served in the

Persian Gulf War (PGW) and 482 veterans who served elsewhere (non-PGW) was

conducted in 1998. Gulf War illness, defined as having chronic symptoms in three

of six domains, occurred in 34% of PGW veterans, 12% of non-PGW veterans who

reported receiving vaccines during the war, and 4% of non-PGW veterans who did

not receive vaccines. The prevalence of Gulf War illness was lowest among PGW

veterans who served on board ship (21%) and highest among those who were in Iraq

and/or Kuwait (42%). Among PGW veterans who served away from battlefield areas,

Gulf War illness was least prevalent among those who departed the region prior

to the war (9%) and most prevalent among those who

departed in June or July of 1991 (41%). Observed patterns suggest that excess

morbidity among Gulf War veterans is associated with characteristics of their

wartime service, and that vaccines used during the war may be a contributing

factor.

PMID: 11092441 [PubMed - indexed for MEDLINE]

********************************************************************************\

***¡ö Before sending this sample, call the DU program office at 1-800-815-7533

so that we can anticipate delivery. A copy of this checklist, and a completed

copy of VA Form 10-9009D, must be faxed to 410-605-7943.

Notification of the results can be expected in approximately 45 days.

VA Form 10-9009E REPRODUCE LOCALLY Page 2

July 1998

*****************************************

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Gulf War Illnesses: Questions About the Presence of Squalene Antibodies

in Veterans Can Be Resolved (Letter Report, 03/29/99, GAO/NSIAD-99-5).

Pursuant to a congressional request, GAO investigated the reports that

the blood samples of some ill Gulf War-era veterans contained antibodies

for squalene, a component of adjuvant formulations used in some

experimental vaccines but not in any licensed vaccines, focusing on

whether: (1) the Department of Defense (DOD) or the National Institutes

of Health (NIH) performed or sponsored research using squalene; (2) DOD

considered using adjuvant formulations in vaccines administered to Gulf

War-era veterans; and (3) any research has detected the presence of

squalene in ill Gulf War-era veterans.

GAO noted that: (1) prior to and following the Gulf War, DOD and NIH

used adjuvant formulations of squalene to perform research on the

development of more effective vaccines; (2) DOD officials stated they

considered, but decided against, using vaccines with experimental

adjuvant formulations during the Gulf War; (3) according to independent

researchers, as part of their treatment of sick Gulf War-era veterans,

they developed and administered a test, referred to as an assay, that

detected antibodies to squalene in the blood of sick Gulf War-era

veterans; (4) the researchers stated this assay is similar to a standard

assay used in other types of research; (5) as of March 1999, the

research has been subjected to peer review, but had not been published;

(6) this process is often lengthy, sometimes taking a year or more; (7)

according to DOD officials, DOD could develop such an assay

inexpensively and test it on a sample of sick Gulf War-era veterans; (8)

however, DOD plans to wait until the research is published before

deciding whether to conduct testing; and (9) given the researchers'

assessment, DOD's comments about the feasibility of developing an assay

and that veterans have been waiting for the past 7 years for answers on

the nature and origin of their illnesses, DOD has the opportunity to

expand on the research already performed.

--------------------------- Indexing Terms -----------------------------

REPORTNUM: NSIAD-99-5

TITLE: Gulf War Illnesses: Questions About the Presence of

Squalene Antibodies in Veterans Can Be Resolved

DATE: 03/29/99

SUBJECT: Veterans

Research reports

Medical research

Disease detection or diagnosis

Testing

IDENTIFIER: Persian Gulf War

** **

** with the message 'info' in the body. **

******************************************************************

NS99005.book GAO United States General Accounting Office

Report to the Honorable Jack Metcalf House of Representatives

March 1999 GULF WAR ILLNESSES

Questions About the Presence of Squalene Antibodies in Veterans

Can Be Resolved

GAO/NSIAD-99-5

GAO/NSIAD-99-5

United States General Accounting Office Washington, D. C. 20548

Lett er

Page 1 GAO/NSIAD-99-5 Gulf War Illnesses

GAO

National Security and International Affairs Division Lett er

B-278779 March 29, 1999 The Honorable Jack Metcalf House of

Representatives

Dear Mr. Metcalf: You expressed concern about reports that the

blood samples of some ill Gulf War- era veterans contained

antibodies for squalene 1 a component of adjuvant formulations

used in some experimental vaccines but not in any licensed

vaccines. 2 As requested, we identified whether (1) the Department

of Defense (DOD) or the National Institutes of Health (NIH)

performed or sponsored research using squalene, (2) DOD considered

using adjuvant formulations in vaccines administered to Gulf War-

era veterans, and (3) any research has detected the presence of

squalene in ill Gulf War- era veterans.

Results in Brief Prior to and following the Gulf War, DOD and NIH

used adjuvant formulations of squalene to perform research on the

development of more effective vaccines. DOD officials stated they

considered, but decided against, using vaccines with experimental

adjuvant formulations during the Gulf War. According to

independent researchers, as part of their treatment of sick Gulf

War- era veterans, they developed and administered a test,

referred to as an assay, that detected antibodies to squalene in

the blood of sick Gulf War- era veterans. The researchers stated

this assay is similar to a standard assay used in other types of

research. As of March 1999, the research had been subjected to

peer review, but had not been published. This process is often

lengthy, sometimes taking a year or more. According to DOD

officials, DOD could develop such an assay inexpensively and test

it on a sample of sick Gulf War- era veterans. However, DOD plans

to wait until the research is published before deciding whether to

conduct testing. Given the researchers' assessment, DOD's comments

about the feasibility

of developing an assay and that veterans have been waiting for the

past 1 Squalene is found in shark liver oil, some vegetable oils,

and the human liver and can also be manufactured through chemical

engineering. Squalane is the hydrogenated form of squalene. When

we use the term squalene by itself, it refers to both squalane and

squalene. 2 An adjuvant is a substance incorporated in a vaccine

to accelerate, enhance, or prolong a specific immune response. An

antigen is a substance that stimulates production of an antibody.

Neither squalane or squalene is a complete adjuvant by itself.

Both serve as vehicles in which adjuvant formulations and vaccine

antigens can be mixed and delivered.

B-278779 Page 2 GAO/NSIAD-99-5 Gulf War Illnesses

7 years for answers on the nature and origin of their illnesses,

DOD has the opportunity now to expand on the research already

performed.

Background Many of the approximately 700,000 veterans of the Gulf

War have reported health problems. Some fear that their illnesses

might be due to exposure to chemicals, pesticides, and other

agents used during the war, including

vaccines administered to protect them against biological warfare

agents. Questions about vaccine adjuvant formulations were raised

to DOD in June 1994. At that time, an immunologist from the

private sector notified the

Defense Science Board that some symptoms being reported by Gulf

War- era veterans were very similar to those of her patients with

autoimmune diseases. These patients had a range of symptoms

affecting more than one of the body systems and the immunologist

believed they were associated with exposure to vaccine adjuvant

formulations. In October 1995, DOD, before a meeting of the

Presidential Advisory Commission on Gulf War illnesses, dismissed

this hypothesis on the grounds that it had administered only

vaccines with aluminum salts as adjuvants. In November 1996 and

again in 1997, the immunologist notified DOD, based on independent

research, that she had found antibodies to squalene in the blood

of a few sick veterans who had served in the military during the

Gulf War. However, DOD has not responded to these findings.

According to the researcher, she continues to be willing to

discuss the

research with DOD. To date, aluminum hydroxide is the only

adjuvant used in vaccines licensed by the Food and Drug

Administration (FDA) in the United States. While widely considered

to be safe, this adjuvant provides only a limited boost in the

immune response, and researchers have long emphasized the critical

need for new, more effective adjuvant formulations. According to

the National Institute of Allergy and Infectious Diseases (NIAID),

the branch of NIH that sponsors most of its vaccine- related

research, a new generation of novel adjuvant formulations are

being developed. These formulations are

intended to enhance and optimize immune responses to vaccines;

enable easier delivery of antigens, and reduce the amount of

antigen and the number of immunizations required for protective

immunization. Squalene is a common component of these new

formulations. As with all drugs and biological products, the

absolute safety of adjuvant formulations can never

B-278779 Page 3 GAO/NSIAD-99-5 Gulf War Illnesses

be guaranteed. 3 Safety concerns have been cited 4 regarding the

use of novel adjuvant formulations in vaccines, including

squalene, and the associated adverse reactions. 5 It has also been

suggested that the safety of vaccines containing these

formulations must be evaluated in conservative ways. 6

DOD and NIH Performed and Sponsored Research With Squalene

DOD and NIAID officials reported that, to help develop more

effective vaccines, they conducted research using adjuvant

formulations with squalene. In all, they performed or sponsored 28

clinical trials on vaccines using adjuvant formulations with

squalene, and 1,749 human subjects participated in these trials.

Prior to the Gulf War, both organizations were devising ways to

induce a rapid response to several vaccines using adjuvant

formulations with squalene. DOD officials stated that they

considered, but

decided against using vaccines with adjuvant formulations

including those with squalene to protect Gulf War troops.

DOD Research Between 1988 and 1998, DOD sponsored 101 clinical

trials on vaccines as part of a process required by FDA for

licensing investigational new drugs (IND). At least 21 of these

trials involved vaccines with adjuvant formulations, and 5 of

these 21 involved adjuvant formulations containing

squalene. These formulations were available from U. S. firms. 7

(See app. I for specific information on these firms and the

development of adjuvant formulations with squalene.) In the five

trials involving squalene, 572 human subjects volunteered and

participated. Of the five trials, two began

before the Gulf War. DOD officials could not confirm whether any

of the 3 J. L. Bussiere et al., " Preclinical Safety Assessment

Considerations in Vaccine Development " In , M. F. and

Newman, M. J. (Eds.) (1995). Vaccine Design: The Subunit and

Adjuvant Approach (New York: Plenum Press), pp. 61- 75. 4

Goldenthal, K. L. et al., " Safety Evaluation of Vaccine Adjuvants:

National ative Vaccine Development Meeting Working Group, "

AIDS Research and Human Retroviruses, vol. 9 (1993), pp. S47- S51.

Lorentzen, J. C. Identification of Arthritogenic Adjuvants of Self

and Foreign Origin. Scandinavian Journal of Immunology, vol. 49

(1999), pp. 45- 50. 5 Adverse reactions are local or systemic.

Local reactions include pain and swelling at the injection site.

Systemic reactions include fevers and toxicity of organs and

systems. 6 M. F. and M. J. Newman, Vaccine Design: The

Subunit and Adjuvant Approach (New York: Plenum Press, 1995) 7

This information was derived from DOD data submitted to FDA and

may not include cooperative research efforts with others.

B-278779 Page 4 GAO/NSIAD-99-5 Gulf War Illnesses

volunteers in studies that DOD sponsored had deployed to the Gulf

War. The five trials are described as follows: In April 1988,

DOD's first clinical trial of an experimental malaria vaccine with

an adjuvant containing squalene was approved, 8 but according to

DOD, doses were actually administered from June 1989 to January

1990. Five volunteers were given the vaccine. In August 1990,

another trial of the malaria vaccine was approved, using

the same adjuvant with squalene on 12 volunteers. 9 In 1994, DOD

began another study on a malaria vaccine containing an adjuvant

with squalene. 10 Both 110 experimental subjects and 11 control

subjects were given the adjuvant. An additional arm of the study,

using human subjects from Gambia, was withdrawn before any

vaccines were given because of concerns about the stability of the

product. In 1995, through a cooperative research and development

agreement, the Chiron Biocine Company and the Walter Army

Institute of Research began a clinical trial of a vaccine for

Human Immunodeficiency Virus (HIV) that contained an adjuvant with

squalene. 11 The vaccine containing squalene was given to 41

healthy volunteers in Thailand, and the adjuvant with squalene

without the rest of the vaccine was given as a placebo to 13

people in a control group.

In 1997, the Walter Army Institute of Research began to

cosponsor another study in Thailand on an HIV vaccine with an

adjuvant formulation containing squalene, which is ongoing. 12

This study will give both the experimental and control subjects

the adjuvant formulation with squalene. Three hundred and eighty

subjects have been recruited for this study; 3 are Americans and

the remaining are Thai citizens.

8 IND 2699. " Safety and Immunogenicity of a Plasmodium falciparum

Malaria Sporozoite Vaccine, R32NS1 81 With DETOX TM As An

Adjuvant. " 9 IND 3714. " The Protective Efficacy of a Plasmodium

falciparum Vaccine, R32NS1 81 and MPL/ CSW as an Adjuvant. " 10 IND

6043. " Plasmodium falciparum Circumsporozite Antigen Vaccine

(Recombinant, Yeast) with Alum, QS21, MPL and SB62 Adjuvant

Combinations. " 11 IND 4096. " A Phase I Trial of Biocine HIV SF2 gp

120/ MF59 Vaccine in Seronegative Thai Volunteers. "

12 IND 7172. " A Phase I/ II Double- blind, Placebo- controlled

study of the Chiron HIV Thai E gp 120/ MF59 Vaccine Administered

alone or Combined with the Chiron HIV SF2 gp120 Antigen in Healthy

HIV- Seronegative Thai Adults. "

B-278779 Page 5 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix II provides further details on these studies, and

appendix III provides a list of DOD research publications on those

trials involving human subjects.

In addition, DOD has conducted several experiments on animals,

using vaccines with adjuvant formulations containing squalene, for

a wide range of diseases, including anthrax, toxic shock, and

malaria. The anthrax vaccine experiments with adjuvant

formulations containing squalene began in 1987, and some of the

results have been presented at conferences and published in

several medical journals. (See app. IV for a list of some of DOD's

animal research on adjuvant formulations with squalene). DOD's

animal studies are of interest for two reasons. First, because

tests on

animals are generally performed before human trials, they

represent the first step of vaccine research and provide a more

complete picture about the state of research on adjuvant

formulations with squalene before the

Gulf War. Second, since vaccines against biological warfare cannot

be tested for efficacy in humans, animal research is considered

essential by researchers.

NIH's Research on Vaccines With Adjuvant Formulations Containing

Squalene

NIAID officials stated they have sponsored vaccine trials on

various adjuvant formulations, including several with squalene.

NIAID's research on vaccines and adjuvant formulations has

increased substantially over the last 10 years. The total number

of active vaccine projects more than doubled, from 212 in 1987 to

539 in 1997. Research involving adjuvant formulations expanded at

an even faster pace, from 13 studies in 1987 to

59 active projects in 1997. NIAID's clinical research on novel

adjuvant formulations involving human subjects began in 1988.

NIAID- sponsored basic/ preclinical studies on adjuvant

formulations with squalene began in 1987, and clinical trials

began at the same time as Operation Desert Storm, in January 1991.

Since then, NIAID has sponsored at least 23 trials of vaccines

involving adjuvant formulations with squalene, with 1,177 human

volunteers. 13 Nineteen of the 23 trials involved an HIV vaccine

tested on a total of 935 volunteers; the 4 remaining trials

involved a vaccine for herpes with 242 subjects. (See app. V for a

list of the 23 studies.

13 Establishing the exact number of studies is difficult because

NIAID's databases often do not specify the adjuvants used in both

preclinical and clinical studies. Also, 2 years after the studies

are completed, the records are routinely destroyed and only an

index is maintained.

B-278779 Page 6 GAO/NSIAD-99-5 Gulf War Illnesses

DOD Officials Report They Considered, but Decided Against, Using

Vaccines With Novel Adjuvent Formulations, Including

Squalene In August 1990, DOD established various committees to

address its concerns about the threat of Iraqi biological warfare

agents and the

insufficient supply of vaccines to immunize all troops against

these agents. These committees identified several problems. They

determined that DOD had neither a sufficient quantity of vaccine

nor the manufacturing capacity to protect the force. It also did

not have sufficient time to administer the

required six anthrax shots over 18 months and faced formidable

logistical problems in giving multiple shots to troops in various

locations in the Persian Gulf region. According to DOD officials,

the use of novel adjuvant formulations for the anthrax vaccine was

rejected because any alteration in the licensed vaccine would

require relicensure, and DOD would not receive FDA approval in

time. Other alternatives were pursued. DOD requested help from

commercial U. S. and foreign vaccine manufacturers; NIH, through

its

National Cancer Institute facility at Fort Detrick, land; and

additional military production facilities at Fort Detrick and

Porton Down, United Kingdom. According to the commercial

manufacturers, they turned DOD down because developing a safe and

effective vaccine takes sustained investment and planning and DOD

had not previously been willing to invest the money and time. DOD

began immunizing troops in Janaury 1991. However, it should be

noted that even if the manufacturing capacity had

been increased, DOD never had the 18- month time span needed to

fully immunize the troops in the Gulf War because of the war's

short duration.

Although DOD awarded contracts to the National Cancer Institute to

produce additional anthrax vaccine and began planning production

of additional botulinum toxoid vaccine at the U. S. Army Medical

Research Institute of Infectious Diseases, also located at Fort

Detrick, the two institutes were unable to begin production before

the war. DOD officials said that botulinum toxoid vaccine was

acquired from Porton Down, United Kingdom, but was not used.

Consequently, according to DOD, the only vaccines against

biological warfare agents anthrax and botulinum toxoid given

during the Gulf War were produced by the Michigan Department of

Public Health. It subsequently became an independent

agency, the Michigan Biologic Products Institute, and was recently

privatized as BioPort. Officials at BioPort said that they have

never used adjuvant formulations containing squalene.

We cannot say definitively whether or not Gulf War- era veterans

were given vaccines with adjuvant formulations containing squalene

for a number of reasons. Although DOD officials told us they did

not administer such

B-278779 Page 7 GAO/NSIAD-99-5 Gulf War Illnesses

vaccines, they stated they did not have documentation on the

process and results of decision- making related to the

administration of vaccines at the time of the Gulf War. Also, some

officials involved in the decisions were no longer employed with

DOD at the time of our review, and we were either unable to locate

them or they declined to be interviewed.

Independent Researchers State They Have Detected

Squalene Antibodies in Gulf War- Era Veterans

In examining the pathology of illnesses afflicting Gulf War- era

veterans, independent researchers examined whether antibodies to

squalene were present in patients who had and had not been

deployed to the Gulf War. Using an assay that they developed the

researchers stated that they

detected squalene antibodies in the blood of sick Gulf War- era

veterans. The immunologist who headed this study and laboratory

researchers at a major university medical center that were

involved in the study shared their methodology and findings with

us. The results of the research have been submitted to a medical

journal to be peer reviewed and published. As

of February 1999, there was no set date for publication. According

to the researchers, the antisqualene antibody assay that they

developed in their study is a variant of the common Western Blot

assay 14 and is similar in format to a test cited in a published

report on silicone antibodies. 15 Using the antisqualene antibody

assay, the independent researchers stated they found most veterans

with Gulf War illnesses in their research had the antibodies to

squalene, regardless of whether they were deployed or not.

Non veterans in the research that were known to have received

adjuvant formulations with squalene as volunteers in clinical

trials of experimental vaccines also had the antibodies to

squalene and had an array of symptoms similar to symptoms of the

Gulf War patients. On the other hand, those participants (in the

control groups) that were healthy with no autoimmune symptoms,

those non- Gulf War veterans with autoimmune diseases of

unknown origin, and those who had received other adjuvant

formulations were found not to have antibodies to squalene. The

independent researchers concluded that, while the reason for the

presence of the

14 The Western Blot assay applies a protein or polymer such as

squalene to test strips, which are then incubated with patient

serum. If the antibody of interest is present, test strips turn

bluish black. A darker color indicates a higher concentration of

antibodies.

15 S. A. Tenenbaum et al., " Use of anti- polymer antibody assay in

recipients of silicone breast implants, " The Lancet, vol. 349

(1997), pp. 449- 454. For correspondence concerning this study see

" Antipolymer antibodies, silicone breast implants, and

fibromyalgia, " The Lancet, vol. 349 (1997), pp. 1170-- 1173.

B-278779 Page 8 GAO/NSIAD-99-5 Gulf War Illnesses

squalene antibodies remains unclear, the presence of these

antibodies could potentially be a contributing factor to Gulf War

illnesses. DOD officials stated they could develop an assay, or

test, for detecting antibodies to squalene. According to these

officials, it would not be expensive to develop the assay and test

it on a sample of Gulf War- era veterans that are sick. However,

they believed that since DOD did not use adjuvants with squalene,

DOD does not need to develop such an assay or to screen the

veterans for the antibodies. Second, squalene is a substance that

occurs naturally in the human body, and they doubted that an assay

could be developed to differentiate antibodies to natural and

manufactured squalene. Third, they noted that squalene is also

found in numerous topical creams that some soldiers could have

used. Finally, DOD officials do not believe that funding squalene

antibodies in veterans would prove that the

antibodies caused Gulf War illnesses. Consequently, DOD intends to

wait until the independent researchers publish their research in a

peer- reviewed journal before deciding whether to conduct testing.

Conclusions and Recommendation

Time is critical for many Gulf War- era veterans who continue to

suffer from illnesses and have been waiting for the past 7 years

for an explanation about the nature of their illnesses. It is

therefore important that DOD takes advantage of any opportunity to

obtain and evaluate additional information on the veterans'

symptoms and potential contributing factors. Independent

researchers, using an assay that they state is similar to standard

research assays, have concluded that squalene antibodies are

present in sick Gulf War- era veterans that participated in their

research and are a potential contributing factor to these

veterans' illnesses. DOD officials stated that it is feasible to

develop and apply an assay to test for squalene antibodies. Yet

for various reasons, including its assertion that it did not use

adjuvant formulations with squalene, DOD plans to wait until the

researchers' research is published before considering whether to

conduct its own

testing. However, publication is usually a lengthy process and may

take more than a year. Given that Gulf War- era veterans have

already waited a significant amount of time for information on

their illnesses, we believe that DOD should act now to expand on

the research already conducted.

Although the origin of the antibodies may be important to assess,

the first step is to determine the extent to which they are

present in a larger group of sick Gulf War- era veterans. We

therefore recommend that the Secretary of Defense review the

independent research that researchers report has revealed the

presence of squalene antibodies in the blood of ill Gulf War- era

B-278779 Page 9 GAO/NSIAD-99-5 Gulf War Illnesses

veterans and conduct its own research designed to replicate or

dispute these results. Agency Comments In written comments on a

draft of our report, DOD disagreed with our recommendation to test

for antibodies for squalene in the blood of ill Gulf War- era

veterans. DOD stated there is no basis for believing veterans were

exposed to vaccines containing squalene. DOD further believes that

the proposed testing for the presence of squalene antibodies will

not appropriately address or assist in resolving the issue of

whether such antibodies may be a contributing cause to the

illnesses of Gulf War- era veterans. Specifically, DOD stated no

experimental vaccines with squalene had been used in U. S. troops

during the Gulf War and that the manufacturer of vaccines verified

it had never used adjuvant formulations containing

squalene. DOD noted that we concluded there was no evidence that

Gulf War- era veterans were given adjuvant formulations containing

squalene, and it therefore believes our proposal to test veterans

seems scientifically and fiscally irresponsible. DOD suggested

that our report be titled Gulf War Illnesses: Gulf War Veterans

Did Not Receive Vaccine Adjuvant

Formulations Containing Squalene. DOD further stated the assay

developed by independent researchers has not been validated

through peer review or publication in scientific literature and

that it is correctly adhering to widely accepted standards by

awaiting such validation before considering the use of the assay

in Gulf War illness studies. It also believed our recommendation

to test for squalene antibodies showed a lack of understanding of

scientific methods. In particular, DOD stated the presence of

antibodies would not establish an

association with adverse health outcomes and establishing an

association would require a statistically meaningful study of

randomly selected Gulf War veterans and non deployed veterans. DOD

noted that any

experimental design to test for this association must be evaluated

for scientific merit through independent peer review.

DOD misstated our finding on whether Gulf War- era veterans may

have received vaccine adjuvant formulations containing squalene.

We did not conclude that Gulf War era veterans were not given

adjuvant formulations containing squalene. Rather, we cannot say

definitively whether or not Gulf War- era veterans were given

these formulations. We have modified the report text to make this

point clear. Furthermore, it was not our

B-278779 Page 10 GAO/NSIAD-99-5 Gulf War Illnesses

intention to focus on how squalene antibodies may have been

introduced into the blood of the veterans. Rather, the focus

should be on the opportunity to resolve whether such antibodies

are present in the blood of ill Gulf War- era veterans, and if so,

whether or not they play a role in their illnesses. In this

respect, the results of the independent research suggesting that

antibodies to squalene are present in ill Gulf War- era veterans

participating in their research cannot be ignored.

We continue to believe that DOD should take this opportunity to

begin addressing and potentially resolving the question of whether

or not squalene antibodies may be contributing to the illnesses of

Gulf War- era

veterans. Specifically, DOD should conduct research designed to

replicate or dispute the independent research results that

revealed the presence of squalene antibodies in the blood of ill

Gulf War- era veterans. We modified our recommendation to clarify

this position. If DOD's research affirms the

presence of these antibodies, additional research should be

conducted that is designed to assess the significance of that

finding. This would simply be a first step in the research process

and would not finally resolve the issue of whether or not squalene

antibodies are a marker for, contribute to, or cause the

illnesses. Follow- on research would be required to address those

issues.

DOD also provided technical comments, which we incorporated as

appropriate. DOD's comments are printed in their entirety in

appendix VI. Scope and Methodology

To develop the information in this report, we conducted multiple

literature searches of public and agency databases and reviewed

both published and unpublished literature on the use of adjuvant

formulations in vaccine, including DOD research protocols and

agency documentation. In addition, we interviewed officials at

DOD, NIH, FDA, and the Veterans Administration. We interviewed

vaccine experts in academia,

pharmaceutical firms, and the American Medical Association and

confirmed the validity of using assays as a means of determining

the presence of antibodies. We also interviewed the immunologist

who headed the independent research and laboratory researchers

from Tulane University in New Orleans who developed the anti-

squalene assay, and they shared their methodology and findings

with us. Finally, we interviewed responsible officials at BioPort.

Our work was completed between August 1997 and August 1998 in

accordance with generally accepted government auditing standards.

B-278779 Page 11 GAO/NSIAD-99-5 Gulf War Illnesses

We are sending copies of this report to other interested

congressional committees. We are also sending copies to the

Honorable Cohen, Secretary of Defense; the Honorable Togo

D. West, Jr., Secretary of Veterans Affairs; and the Honorable

Donna E. Shalala, Secretary of Health and Human Services. Copies

will also be made available to others upon

request. If you have any questions or would like additional

information, please contact me at (202) 512- 3092. Major

contributors to this report were Sushil K. Sharma and Dan

. Sincerely yours,

Kwai- Cheung Chan Director, Special Studies

and Evaluations

Page 12 GAO/NSIAD-99-5 Gulf War Illnesses

Contents Letter 1 Appendix I Development of Adjuvant Formulations

With Squalene

15 Appendix II DOD's Clinical Trials on Novel Vaccines With

Adjuvant Formulations Containing Squalene

17 Appendix III DOD's Published Research on Vaccines With Adjuvant

Formulations Containing Squalene That Involved Human Subject

Volunteers

18 Appendix IV DOD's Animal Research on Adjuvant Formulations With

Squalene

19

Page 13 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix V National Institute of Health Studies Using Adjuvants

With Squalene

21 Appendix VI Comments From the Department of Defense

22 Tables Table I. 1: Pharmaceutical Firms' Adjuvant Formulations

That May

Contain Squalene or Squalane 16

Abbreviations

DOD Department of Defense FDA Food and Drug Administration HIV

Human Immunodeficiency Virus IND Investigational new drgus NIAID

National Institute of Allergy and Infectious Diseases NIH National

Institutes of Health

Page 14 GAO/NSIAD-99-5 Gulf War Illnesses

Page 15 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix I Development of Adjuvant Formulations With Squalene

Appendi x I

Biotechnology research and development of adjuvant formulations

with squalene began in the 1970s and the first clinical study

began in 1984. At the time of the Gulf War, at least three firms

Ribi ImmunoChem Research Inc. of Hamilton, Montana; Chiron of

Alameda, California; and Syntex of Palo Alto, California had

developed adjuvant formulations with squalene

and were distributing them for vaccine research and development.

Research on adjuvant formulations with squalene has continued. At

least seven biotechnology and pharmaceutical firms have developed

nine different adjuvant formulations that may contain squalene. In

five of the adjuvant formulations, squalene or squalane is always

a component, and in the other four, it is used optionally (see

table I. 1). According to Chiron, its adjuvant formulation with

squalene has been tested on over 9,000 human subjects. Ribi

ImmunoChem reports that its adjuvant formulations with squalene

have been tested on over 1,000 human subjects.

Appendix I Development of Adjuvant Formulations With Squalene

Page 16 GAO/NSIAD-99-5 Gulf War Illnesses

Table I. 1: Pharmaceutical Firms' Adjuvant Formulations That May

Contain Squalene or Squalane

Note: Much of this information in this table is from F. R. Vogel

and M. V. , Chapter 7, " A compendium of Vaccine Adjuvants

and Excipients, " Vaccine Design: The Subunit and Adjuvant

Approach, M. F. and M. J. Newman, (New York: Plenum Press,

1995). Additional and updated information was gathered from F. R.

Vogel and other sources.

Name of adjuvant formulation

Name of pharmaceutical firm Compound used

Always contains squalane or squalene

Squalene or squalane is used optionally

Antigen Formulation IDEC

Pharmaceuticals Corporation

Squalane Yes No CRL 1005 (Block Copolymer P1205)

Vaxcel Corporation Squalene No Yes Detox RibiImmunoChem Research,

Inc. Squalane Yes No Gerbu Adjuvant CC Biotech

Corporation Squalane No Yes GMDP Peptech, Ltd., UK Squalane No Yes

MF59 Chiron Squalene Yes No MPL RibiImmunoChem Research, Inc.

Squalene No Yes

Ribi adjuvant system RibiImmunoChem Research, Inc. Squalene Yes No

Syntex adjuvant formulation (SAF)

Syntex Research Squalane Yes No

Page 17 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix II DOD's Clinical Trials on Novel Vaccines With Adjuvant

Formulations Containing Squalene Appendi x I I

The following table identifies vaccine trials with adjuvant

formulations that contained squalene and squalane conducted by DOD

under the Food and Drug Administration's (FDA) process for

approving investigational new drugs (IND). New drugs and vaccines

under development generally have to be tested in humans for safety

and efficacy before they are approved for general human use.

Therefore, FDA grants IND waivers allowing human subject

experiments after reviewing information on the product, its

manufacture and testing, and the proposed clinical study.

a Date IND approved by FDA's Human Subject Research Review Board.

b As of December, 1997. c The control group received a placebo

consisting of the adjuvant MF59 alone without the rest of the

vaccine.

Date IND approved for human subject research a IND

number Number of human subjects Country of

subjects Vaccine Adjuvant

containing squalene or squalane

4/ 27/ 88 2699 5 United States Malaria Detox 8/ 8/ 90 3714 12

United States Malaria Detox 12/ 7/ 94 6043 121 b United States

Malaria MPL 2/ 8/ 95 4096 41 vaccine,

13 placebo c Thailand HIV MF59 9/ 18/ 97 7172 300 vaccine,

80 placebo c 377- Thailand 3- United States HIV MF59

Total 5 572 Malaria HIV Detox

MPL MF59

INDs using U. S. citizens 3 138 Malaria HIV Detox

MPL MF59

INDs using foreign citizens 2 434 HIV MF59

Page 18 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix III DOD's Published Research on Vaccines With Adjuvant

Formulations Containing Squalene That Involved Human Subject

Volunteers Appendi x I I I

Rickman, L. et al. " Use of adjuvant containing mycobacterial cell-

wall skeleton monophosphoryl lipid A, and squalane in malaria

circumsporozite protein vaccine. " Lancet. Vol. 337, 1991, pp. 998-

1001. Hoffman, S. L. et al. " Safety, immunogenicity, and efficacy

of a malaria sporozite vaccine administered with monophosphoryl

lipid A, cell- wall skeleton of mycobacteria, and squalene as

adjuvant. " American Journal of Tropical Medical Hygiene. Vol. 51/

5, 1994, pp. 603- 612.

Stoute, J. A. et al. " A preliminary evaluation of recombinant

circumsporozoite protein vaccine against plasmodium falciparum

malaria. " New England Journal of Medicine. Vol. 336, 1997, pp. 86-

91.

Page 19 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix IV DOD's Animal Research on Adjuvant Formulations With

Squalene Appendi x I V

Anthrax Iacono- Connors, L. et al. " Protection against Anthrax

with Recombinant Virus- Expressed Protective Antigen in

Experimental Animals, " Infection

and Immunity. Vol. 59, 1991, pp. 1961- 1965. Ivins, B. et al.

" Experimental anthrax vaccines: efficacy of adjuvants combined

with protective antigen against an aerosol Bacillus anthraces

spore challenge in guinea pigs. " Vaccine, Vol. 13, 1995, pp. 1779-

1784.

Ivins, B. et al. " Experimental Anthrax Vaccines: Efficacy Studies

in Guinea Pigs. " Abstracts of the 93rd General Meeting of the

American Society for Microbiology. 1993, p. 160.

Ivins, B. et al. " Comparative efficacy of experimental anthrax

vaccine candidates against inhalation anthrax in rhesus macaques. "

Vaccine. Vol. 16, 1998, pp. 1141- 1148.

Ivins, B. et al. " Cloned Protective Activity and Progress in

Development of Improved Anthrax Vaccines. " Salisbury Medical

Bulletin Special Supplement. 1990, pp. 86- 88. Ivins, B. et. al.

" Immunization against Anthrax with Bacillus anthraces Protective

Antigen Combined with Adjuvants. " Infection and Immunity. Vol. 60,

1992, pp. 662- 668.

Ivins, B. et. al. " Adjuvant Efficacy in Experimental Anthrax

Vaccines: Protection Studies in Guinea Pigs. " Abstracts of the

91st General Meeting of the American Society for Microbiology.

1991, p. 121.

Ivins, B. et. al. " Vaccine Efficacy of Bacillus Anthraxis

Protective Antigen Produced in Prokayotic and Iukaryotic Cells. "

Abstracts of the 94th General Meeting of the American Society of

Microbiology, 1994, p. 150.

Little S. F. et. al. " Protection against experimental anthrax

infection using fragments of Protective antigen. " Proceedings of

the International Workshop on Anthrax. Vol. 87, 1996, p. 129.

Little S. F. et al. " Passive Protection by Polyclonal Antibodies

against Bacillus anthraces Infection in Guinea Pigs. " Infection

and Immunity. Vol. 65, 1997, pp. 5171- 5175.

Appendix IV DOD's Animal Research on Adjuvant Formulations With

Squalene

Page 20 GAO/NSIAD-99-5 Gulf War Illnesses

Malaria Malik A. et al. " Induction of cytotoxic T lymphocytes

against the Plasmodium falciparum circumsporozoite protein by

immunization with soluble recombinant protein without adjuvant, "

Infection and Immunity.

Vol. 61, 1993, pp. 5062- 5066. Toxic Shock Syndrome Stiles, B. et

al. " Biological Activity of Toxic Shock Syndrome Toxin 1 and a

Site- Directed Mutant, H135A, in a lipopolysaccharide- Potentiated

Mouse Lethality Model. " Infection and Immunity. Vol. 63,1995, pp.

1229- 1234.

Page 21 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix V National Institute of Health Studies Using Adjuvants

With Squalene Appendi x V

a NIAID is the National Institute of Allergy and Infectious

Diseases, AVEG is the AIDS Vaccine Evaluation Group, and DIR is

the Division of Intramural Research.

Date Investigational New Drug (IND) study began Vaccine Institute

IND number Adjuvant with squalene No. of subjects

1/ 28/ 91 HIV NIAID/ AVEG a 005A MF 59 16 3/ 22/ 91 HIV NIAID/

AVEG 005B MF 59 46 10/ 1/ 91 Herpes NIAID/ DIR a 92- I- 0267 MF 59

40 10/ 29/ 91 HIV NIAID/ AVEG 005C MF 59 14 12/ 19/ 91 HIV NIAID/

AVEG 007A MF 59 32 2/ 04/ 92 HIV NIAID/ AVEG 007B MF 59 17 11/ 16/

92 HIV NIAID/ AVEG 007C MF 59 10 07/ 28/ 92 HIV NIAID/ AVEG 008 MF

59 14 10/ 1/ 92 Herpes NIAID/ DIR 93- I- 0141 MF 59 174 12/ 09/ 92

HIV NIAID/ AVEG 201 MF 59 149 5/ 19/ 93 HIV NIAID/ AVEG 012A MF 59

15 6/ 03/ 93 HIV NIAID/ AVEG 015 MF 59 30 6/ 03/ 93 HIV NIAID/

AVEG 015 MPL 30 6/ 03/ 93 HIV NIAID/ AVEG 015 SAF/ 2 30 10/ 1/ 93

Herpes NIAID/ DIR 94- I- 0086 MF 59 18 10/ 12/ 93 HIV NIAID/ AVEG

012B MF 59 59 5/ 11/ 95 HIV NIAID/ AVEG 022 MF 59 59 9/ 14/ 95 HIV

NIAID/ AVEG 024 MF 59 30 10/ 1/ 95 Herpes NIAID/ DIR 96- I- 0024

MF 59 10 7/ 10/ 96 HIV NIAID/ AVEG 022A MF 59 129 2/ 06/ 96 HIV

NIAID/ AVEG 026 MF 59 85 7/ 31/ 96 HIV NIAID/ AVEG 029 MF 59 28 5/

22/ 97 HIV NIAID/ AVEG 202 MF 59 142

Total INDs and subjects 23 1177

Page 22 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix VI Comments From the Department of Defense Appendi x VI

Appendix VI Comments From the Department of Defense

Page 23 GAO/NSIAD-99-5 Gulf War Illnesses

Appendix VI Comments From the Department of Defense

Page 24 GAO/NSIAD-99-5 Gulf War Illnesses (713014) Let t er

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posted December 19, 2004 11:41

You can be tested for ASA (Anti-Squalene Antibodies), however I don't know if

the VA will test for this. I would call the VA/Environmental Agents Service near

you and ask if they can test you for it.

http://www.milvacs.org/Sick/Mycoplasm.cfm

Squalene, an orgamic polymer which occurs naturally in the human body, is, in

remanufactured form, an adjuvant, or vaccine " booster, " used in several

experimental vaccines. The purpose of such an adjuvant is to boost the immune

system's reaction to the vaccine. It is illegal for use on human beings in the

United States and Great Britain. There is evidence that when injected, squalene

is responsible for arthritic conditions and pain. Squalene appears to be highly

reactive when injected, although not as reactive when ingested orally.

Although the Dept. of Defense denied the presence of Squalene in the anthrax

vaccine for many years, the FDA tested several lots for the presence of the

adjuvant, and found it - in varying levels. Those lots are (ppb=parts per

billion):

AVA 020 - 11 ppb squalene

AVA 030 - 10 ppb squalene

AVA 038 - 27 ppb squalene

AVA 043 - 40 ppb squalene

AVA 047 - 83 ppb squalene

Squalene has also been found in the vaccine administered in Great Britain,

although the Ministry also denied its presence. See MOD (Ministry of Defense -

UK - ANTHRAX VACCINE CONTAINS SQUALENE)

Recent research by Pamela B. Asa, B. , and F. Garry links

the anthrax vaccine to Gulf War Syndrome through the presence of squalene

antibodies, as noted in the introduction to their report:

" Date: 2002-07-15 Received August 15, 2001, and in revised form October 26,

2001 "

" We previously reported that antibodies to squalene, an experimental vaccine

adjuvant, are present in persons with symptoms consistent with Gulf War Syndrome

(GWS) (P. B. Asa et al., Exp. Mol. Pathol 68, 196-197, 2000). The United States

Department of Defense initiated the Anthrax Vaccine Immunization Program (AVIP)

in 1997 to immunize 2.4 million military personnel. Because adverse reactions in

vaccinated personnel were similar to symptoms of GWS, we tested AVIP

participants for anti-squalene antibodies (ASA). In a pilot study, 6 of 6

vaccine recipients with GWS-like symptoms were positive for ASA. In a larger

blinded study, only 32% (8/25) of AVIP personnel compared to 15.7% (3/19) of

controls were positive (P 0.05). Further analysis revealed that ASA were

associated with specific lots of vaccine. The incidence of ASA in personnel in

the blinded study receiving these lots was 47% (8/17) compared to an incidence

of 0% (0/8; P 0.025) of the AVIP participants receiving other lots of

vaccine. Analysis of additional personnel revealed that in all but one case

(19/20; 95%), ASA were restricted to personnel immunized with lots of vaccine

known to contain squalene. Except for one symptomatic individual, positive

clinical findings in 17 ASA-negative personnel were restricted to 4 individuals

receiving vaccine from lots containing squalene. ASA were not present prior to

vaccination in pre-immunization sera available from 4 AVIP personnel. Three of

these individuals became ASA positive after vaccination. These results suggest

that the production of ASA in GWS patients is linked to the presence of squalene

in certain lots of anthrax vaccine. 2002 Elsevier Science (USA) "

**************************************************************************

THE FOLLOWING COMES FROM THE VA SITE @ http://www.va.gov/ms/

Question :

I served from 1987-2001 and I have MS. What benefits if any am I eligible for

with the VA?

Answer :

If you were honorably discharged from a branch of service, then you may be

eligible for medical care, including medications and equipment, from the VA. The

majority of veterans who apply for services are eligible.

To determine your eligibility, go to the Enrollment Clinic at a VA and complete

an Application for Health Benefits (e.g. Form 10-10EZ or Means Test). This form

requires financial information. Previously the VA did not consider income in

determining eligibility but this has changed in recent years due to the

increasing number of veterans seeking services. Veterans whose income exceeds

the VA's income guidelines (these vary by geographic area to reflect differences

in cost of living, etc.) and are not service connected, fall into priority group

8. Delivery of services is not mandatory for these veterans. HOWEVER, veterans

in this situation can apply for hardship based on financial or medical

circumstances. The enrollment clerk can assist you in doing so. Veterans who are

severely and permanently disabled may meet the criteria for Catastrophic

Disability. This moves a veteran into a higher priority group (5) and makes

delivery of services mandatory.

If you had symptoms of MS in the military or within seven years after honorable

discharge, you may be eligible for service-connected disability. If this is the

case, complete the Veterans Application for Compensation and/or Pension (VA form

21-526) available online (http://www.va.gov) or at your Regional Office and

return it to the Regional Office for processing. Veterans service organizations,

such as the Paralyzed Veterans of America (http://www.pva.org/), United Spinal

Association (http://www.unitedspinal.org/), and Disabled American Veterans

(http://www.dav.org/) are good support resources.

Remember to bring your DD214 with you to expedite the enrollment process. If you

never received your DD214 or it has been lost, you can contact the National

Personnel Records Center in St. Louis, MO, at 314-801-0880 to request a copy.

***************************************************************

Regulations on Vaccine Injury

Bringing this forward from a previous thread, as it may help those who did not

deploy to the AOR:

http://www.gulfwarvets.com/ubb/Forum1/HTML/000201.html

Department of Memorandum

Veterans Affairs

Date: May 14, 2002 VAOPGCPREC 4-2002

From: General Counsel (022)

Subj: Meaning of “Injury” for Purposes of Active Service – 38 U.S.C. § 101(24)

**************************

Director, Compensation and Pension Service (21)

QUESTION PRESENTED:

Whether a former member of the Army Reserve who received two anthrax

inocu-lations during inactive duty training and who alleges suffering from

chronic fa-tigue and chronic Lyme-like disease as a result of these inoculations

may be considered to have been disabled by an injury in determining whether the

mem-ber incurred disability due to active service.

DISCUSSION:

1. The claimant had active duty service in the United States Army from May 29,

1995, to June 18, 1999, and was then assigned to the Army Reserve. In

prepa-ration for a required two-week tour of duty in Korea, the claimant

received three anthrax inoculations, the first two of which were received while

on inactive duty training on February 12 and March 11, 2000. The claimant

received the third in-oculation on March 25, 2000, while in civilian status. The

claimant was deployed to Korea from April 10, 2000, to April 24, 2000. The

claimant has filed a claim with the Department of Veterans Affairs (VA) seeking

service connection for chronic fatigue and chronic Lyme-like illness claimed to

have resulted from the anthrax inoculations.

2. Pursuant to 38 U.S.C. §§ 1110 and 1131, service-connected disability

com-pensation may be paid for disability resulting from injury suffered or

disease con-tracted in line of duty “in the active military, naval, or air

service.” Sec-tion 101(24) defines the term “active military, naval, or air

service” as including “active duty, any period of active duty for training

during which the individual con-cerned was disabled or died from a disease or

injury incurred or aggravated in line of duty, and any period of inactive duty

training during which the individual concerned was disabled or died from an

injury incurred or aggravated in line of duty.” (Emphasis added.) Thus, in the

case of inactive duty training, only if the individual suffered an “injury”

during such service can disability resulting from such service provide a basis

of eligibility for disability compensation.

3. The question of what constitutes an “injury” for purposes of section 101(24)

must be considered in light of three previous General Counsel opinions in which

we analyzed the distinction between “injury” and “disease” under that statute.

One such opinion, VAOPGCPREC 86-90 (O.G.C. Prec. 86-90), concerned whether a

heart attack sustained following heavy exertion while on inactive duty training

was an injury within the meaning of section 101(24). Medical evidence in that

case indicated that the heart attack was the result of coronary artery dis-ease,

which existed prior to the training period, although the event may have been

precipitated by physical exertion. On those facts, we concluded that the

claimant’s heart attack was not caused by an injury, but rather was attributable

to disease.

4. In VAOPGCPREC 86-90, we examined the medical cause of the heart attack. We

noted the consensus among medical specialists that excessive effort and strain

cannot damage a normal heart and concluded that the heart attack was the result

of a disease process. We further concluded that Congress intended to ex-clude

“nontraumatic incurrence or aggravation of a disease process, and that

manifestations of cardiovascular disease, such as heart attacks of nontraumatic

origin, fall within the excluded class of disability, i.e., do not constitute

injuries under the statute.” In v. Brown, 5 Vet. App. 484, 487 (1993),

aff’d, 26 F.3d 141 (Fed. Cir. 1994), the United States Court of Veterans Appeals

con-cluded that VAOPGCPREC 86-90 is consistent with the governing statutes and

Congress’ policy reflected in those statutes. We note that the focus of our

hold-ing in VAOPGCPREC 86-90 was clearly on the non-traumatic nature of the

cause of the heart attack. We may assume that a heart attack

caused by a traumatic external event that is independent of a disease process,

e.g., an elec-tric shock, may be considered an injury.

5. VAOPGC 6-86 (3-27-86) followed and relied upon what was formerly Op. G.C.

1-81 (subsequently reissued and redesignated as VAOPGCPREC 86-90). Although

VAOPGC 6-86 is not precedential, it illustrates how the opinion now designated

VAOPGCPREC 86-90 has been applied. In VAOPGC 6-86, we de-termined that a

claimant who received an influenza vaccination by injection while on inactive

duty training and subsequently developed Guillain-Barre syndrome did not incur a

disability resulting from an injury for purposes of section 101(24). Referencing

what is now VAOPGCPREC 86-90, we reasoned that the term “in-jury” denotes harm

from external trauma, while the term “disease” refers to some type of internal

infection or degenerative process. The opinion cited several sources for the

proposition that the term “trauma” commonly refers to the applica-tion of

external force or violence. We further reasoned that, under modern medi-cal

practice, the routine insertion of a hypodermic needle into the body

is not commonly considered to involve application of external force or violence

that is characteristic of injury. However, we recognized that an injection could

be con-sidered to have caused a traumatic injury if contact with the needle

caused last-ing nerve or tissue damage.

6. Most recently, in VAOPGCPREC 8-2001, we held that an individual who suf-fers

from post-traumatic stress disorder (PTSD) as a result of a sexual assault that

occurred during inactive duty training may be considered disabled by an

“in-jury” for purposes of section 101(2) and (24). This conclusion was based

upon the analysis of the preceding General Counsel opinions indicating that

“injury” refers to the results of an external trauma rather than a degenerative

process and the fact that, according to the Diagnostic and Statistical Manual of

Mental Disorders, Fourth Edition, of the American Psychiatric Association, at

427 (diag-nostic criterion A), a diagnosis of PTSD requires experiencing a

traumatic event.

7. The concept exemplified by these VA General Counsel opinions is that

“injury” refers to the results of an external trauma, rather than a degenerative

process. While, as noted in VAOPGC 6-86, “trauma” frequently is defined with

reference to external force or violence, the term may commonly be considered to

encompass injury to living tissue caused by an extrinsic agent. Webster’s Ninth

New Collegiate Dictionary 1256 (1990). In this regard, we believe that

considera-tion of the nature of vaccines is helpful in resolving the issue of

whether introduc-tion of a vaccine into the body may constitute trauma for

purposes of determining the nature of harm resulting from the vaccine.

8. A vaccine is a suspension of attenuated or killed microorganisms or of

anti-genic proteins derived from them. Dorland’s Illustrated Medical Dictionary

1787 (28th ed. 1994). Vaccines artificially induce the immune system to produce

anti-bodies that will attack invading organisms and prevent disease. National

Institute of Allergy and Infectious Diseases, How Vaccines Work, available at

http://www.niaid.nih.gov/daids/vaccine/how.htm. Although vaccines and mass

immunization programs have been extremely successful in protecting the public

health against dangerous diseases, “available data indicate that some vaccines

are associated with rare but serious adverse effects.” The Anthrax Vaccine: Is

It Safe? Does It Work? at 85. An adverse event following a vaccination may be

either local or systemic. Id. at 86. The duration of these events may be acute

or chronic, and adverse health effects may range from mild to severe. Id.

9. The foregoing discussion indicates that inoculation with a vaccine involves

the intro-duction of a foreign substance into the body and that, while the

substance is intended to and generally does have a beneficial effect, adverse

reactions, sometimes of a severe nature, may result. Further, based on the above

discussion, we believe that the term “injury” in section 101(24) may be

interpreted to include harm not only from a violent en-counter but also from

exposure to a foreign substance, such as a vaccine. We recog-nize that in our

non-precedential opinion VAOPGC 6-86 we concluded that harm result-ing from an

influenza vaccination would not be considered to have resulted from an in-jury.

However, VAOPGC 6-86 focused on harm caused by the “routine insertion of a

hypodermic needle into the body” and on the absence of external force or

violence, rather than on the introduction of an extrinsic agent to body tissue.

We believe the common understanding of the concept of “trauma,” which

is recognized as the cause of “injury,” encompasses a broader definition than

the one applied in VAOPGC 6-86 and that such broader definition includes serious

adverse effects on body tissue or systems resulting from introduction of a

foreign substance. Thus, an adverse reaction to a vac-cination may be considered

an “injury” as that term is used in 38 U.S.C. § 101(24).

10. This conclusion is consistent with VAOPGCPREC 86-90, in which the harm

suffered (a heart attack) did not result from an external force or substance,

but rather from a pre-existing disease. This conclusion is also consistent with

VA-OPGCPREC 8-2001, in which we recognized that a condition (in that case PTSD)

that has characteristics of a disease may be considered to be the result of an

injury, where it resulted from an external assault.

HELD:

If evidence establishes that an individual suffers from a disabling condition as

a result of administration of an anthrax vaccination during inactive duty

training, the individual may be considered disabled by an “injury” incurred

during such training as the term is used in 38 U.S.C. § 101 (24), which defines

“active military, naval, or air service” to include any period of inactive duty

training during which the indi-vidual was disabled or died from an injury

incurred or aggravated in line of duty.

Consequently, such an individual may be found to have incurred disability in

ac-tive military, naval, or air service for purposes of disability compensation

under 38 U.S.C. § 1110 or 1131.

Tim S. McClain

**********************************************************************

ALSO PLEASE TEST FOR THE FOLLOWING

( This testing is if you think you have been injured by anthrax vaccine or

showing autoimmune symptoms )

There are a number of blood tests which may be of help in diagnosing your

husband's illness. If he has autoimmune disease following squalene exposure,

tests include, but are not limited to: ANA, rheumatoid factor, ESR, CRP, CPK,

thyroid profile with TSH, anti-thyroid microsomal antibodies, antiphospholipid

antibodies, antineuronal antibodies, CBC with differential, ANCA, complement C3

and C4. The results from these tests may lead to further testing. If there are

neurologic symptoms, consulting a neurologist who deals with autoimmune

neurologic disease would be helpful. For neuropathies, EMG/NCV may be indicated.

If there is a question of seizures, EEG's will be in order. Tests may need to be

repeated over time. I hope this will help him get the answers he needs. Best

wishes, Pam Asa, Ph.D. ( Tulane University )

**********************************************************************

Here is an Index to Disability Examination Worksheets and links to individual

exams I got from another Forum.

Main page:

www.vba.va.gov/bln/21/ben.../index.htm

Index to Disability Examination Worksheets

" These 56 Disability Examination Worksheets are in use both by the doctors of

VHA (Veterans Health Administration) who do the disability examinations and by

the rating specialists, hearing officers, and Decision Review Officers of VBA

(Veterans Benefits Administration) who do the disability evaluations. "

Acromegaly www.vba.va.gov/bln/21/ben...sexm01.htm

Aid and Attendance or Housebound Examination

www.vba.va.gov/bln/21/ben...sexm02.htm

Arrhythmias www.vba.va.gov/bln/21/ben...sexm03.htm

Arteries, Veins, and Miscellaneous www.vba.va.gov/bln/21/ben...sexm04.htm

Audio www.vba.va.gov/bln/21/ben...sexm05.htm

Bones (Fractures and Bone Disease) www.vba.va.gov/bln/21/ben...sexm06.htm

Brain and Spinal Cord www.vba.va.gov/bln/21/ben...sexm07.htm

Chronic Fatigue Syndrome www.vba.va.gov/bln/21/ben...sexm08.htm

Cold Injury Protocol Examination www.vba.va.gov/bln/21/ben...sexm09.htm

Cranial Nerves www.vba.va.gov/bln/21/ben...sexm10.htm

Cushing's Syndrome www.vba.va.gov/bln/21/ben...sexm11.htm

Dental and Oral www.vba.va.gov/bln/21/ben...sexm12.htm

Diabetes Mellitus www.vba.va.gov/bln/21/ben...sexm13.htm

Digestive Conditions, Miscellaneous www.vba.va.gov/bln/21/ben...sexm14.htm

Ear Disease www.vba.va.gov/bln/21/ben...sexm15.htm

Eating Disorders (Mental Disorders) Changed June 13, 2002

www.vba.va.gov/bln/21/ben...sexm16.htm

Endocrine Diseases, Miscellaneous www.vba.va.gov/bln/21/ben...sexm17.htm

Epilepsy and Narcolepsy www.vba.va.gov/bln/21/ben...sexm18.htm

Esophagus and Hiatal Hernia www.vba.va.gov/bln/21/ben...sexm19.htm

Eye Examination www.vba.va.gov/bln/21/ben...sexm20.htm

Feet www.vba.va.gov/bln/21/ben...sexm21.htm

Fibromyalgia www.vba.va.gov/bln/21/ben...sexm22.htm

General Medical Examination www.vba.va.gov/bln/21/ben...sexm23.htm

Genitourinary Examination www.vba.va.gov/bln/21/ben...sexm24.htm

Guidelines for Disability Examinations in Gulf War Veterans

www.vba.va.gov/bln/21/ben...sexm25.htm

Gynecological Conditions and Disorders of the Breast

www.vba.va.gov/bln/21/ben...sexm26.htm

Hand, Thumb, and Fingers www.vba.va.gov/bln/21/ben...sexm27.htm

Heart www.vba.va.gov/bln/21/ben...sexm28.htm

Hemic Disorders www.vba.va.gov/bln/21/ben...sexm29.htm

Hiv-Related Illness www.vba.va.gov/bln/21/ben...sexm30.htm

Hypertension www.vba.va.gov/bln/21/ben...sexm31.htm

Infectious, Immune, and Nutritional Disabilities

www.vba.va.gov/bln/21/ben...sexm32.htm

Initial Evaluation for Post-Traumatic Stress Disorder (PTSD) Changed June 13,

2002 www.vba.va.gov/bln/21/ben...sexm43.htm

Intestines (Large and Small) www.vba.va.gov/bln/21/ben...sexm33.htm

Joints (Shoulder, Elbow, Wrist, Hip, Knee, and Ankle)

www.vba.va.gov/bln/21/ben...sexm34.htm

Liver, Gall Bladder, and Pancreas www.vba.va.gov/bln/21/ben...sexm35.htm

Lymphatic Disorders www.vba.va.gov/bln/21/ben...sexm36.htm

Mental Disorders (Except Initial PTSD and Eating Disorders) Changed June 13,

2002 www.vba.va.gov/bln/21/ben...sexm37.htm

Mouth, Lips, and Tongue www.vba.va.gov/bln/21/ben...sexm38.htm

Muscles www.vba.va.gov/bln/21/ben...sexm39.htm

Neurological Disorders, Miscellaneous www.vba.va.gov/bln/21/ben...sexm40.htm

Nose, Sinus, Larynx, and Pharynx www.vba.va.gov/bln/21/ben...sexm41.htm

Peripheral Nerves www.vba.va.gov/bln/21/ben...sexm42.htm

Prisoner of War Protocol Examination www.vba.va.gov/bln/21/ben...sexm44.htm

Pulmonary Tuberculosis and Mycobacterial Diseases

www.vba.va.gov/bln/21/ben...sexm45.htm

Rectum and Anus www.vba.va.gov/bln/21/ben...sexm46.htm

Residuals of Amputations www.vba.va.gov/bln/21/ben...sexm47.htm

Respiratory (Obstructive, Restrictive, and Interstitial)

www.vba.va.gov/bln/21/ben...sexm48.htm

Respiratory Diseases, Miscellaneous www.vba.va.gov/bln/21/ben...sexm49.htm

Review Examination for Post-Traumatic Stress Disorder (PTSD) Changed June 13,

2002 www.vba.va.gov/bln/21/ben...sexm56.htm

Scars www.vba.va.gov/bln/21/ben...sexm50.htm

Sense of Smell and Taste www.vba.va.gov/bln/21/ben...sexm51.htm

Skin Diseases (Other than Scars) www.vba.va.gov/bln/21/ben...sexm52.htm

Spine (Cervical, Thoracic, and Lumbar) Changed December 11, 2002

www.vba.va.gov/bln/21/ben...sexm53.htm

Stomach, Duodenum, and Peritoneal Adhesions

www.vba.va.gov/bln/21/ben...sexm54.htm

Thyroid and Parathyroid Diseases www.vba.va.gov/bln/21/ben...sexm55.htm

********************************************************************************\

*

Smallpox easily treated and prevented with homeopathy

History of smallpox (many lies in what we are told)

http://www.nccn.net/~wwithin/smallpox.htm

http://www.zwire.com/site/news.cfm?newsid=13900319 & BRD=1719 & PAG=461 & dept_id=

25271 & rfi=6

Experimental smallpox vaccine tested in St. Louis

DAVE WHALEY, The Telegraph 02/06/2005

ST. LOUIS -- Saint Louis University is one of four sites in the country

participating in a clinical trial to study a " next-generation " smallpox

vaccine.

VaxGen Inc. is developing the experimental vaccine -- for now named LC16m8

-- in partnership with the Chemo-Sero Therapeutic Research Institute in

Japan. The vaccine will be compared to Dryvax, the only smallpox vaccine

currently licensed for use in the United States.

" Although smallpox was eradicated in the United States years ago, the

possibility that it may be used in a bioterrorist act has prompted the

government to seek attenuated smallpox vaccines for the country’s national

stockpile, " said Dr. Sharon Frey, principal investigator in the study.

Attenuated, or modified, vaccines are designed to be safer than

conventional live-virus vaccines such as Dryvax.

The clinical trial is enrolling study volunteers to evaluate the safety of

the vaccine, as well as its ability to induce an immune response. Although

LC16m8 has been licensed and safely used in Japan for more than 50,000

children, as well as in laboratory, medical and emergency response

personnel, getting licensed for use in the United States requires

completion of studies according to Food and Drug Administration standards.

A total of 150 volunteers are being sought for a 52-week study, with 120

receiving LC16m8 and 30 receiving Dryvax. Study volunteers will be screened

for risk factors. The screening process includes a medical history,

physical exam, and a panel of cardiac and lab tests.

All volunteers will continue to receive safety evaluations in the clinic

after vaccination and will return for regular assessments. Frey stressed

that no one will be exposed to smallpox as part of the clinical study.

To be eligible, volunteers must be between 18 and 33 years old, in good

health with no chronic illness, no heart disease, no immune system

problems, and no eczema or other significant skin conditions. Volunteers

must not previously have been vaccinated against smallpox.

Those who have significant contact with children under the age of 1 or who

are pregnant or breastfeeding will be excluded.

Qualified volunteers will receive lab and cardiac tests, and the vaccine,

at no charge.

For more information, call the Saint Louis University Center for Vaccine

Development at (314) 977-6333.

dwhaley56@...

©The Telegraph 2005

*****

http://www.vaxgen.com/products/smallpox_LC16m8.html

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_ui

ds=2993828 & dopt=Abstract

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve & db=PubMed & list_ui

ds=3554809 & dopt=Abstract

http://news-service.stanford.edu/news/2005/january26/med-smallpox-012605.html

also experimenting at Stanford in CA

http://vir.sgmjournals.org/cgi/content/abstract/68/10/2705

http://www.cojoweb.com/Biodefense4.html

" An attractive candidate is the LC16m8 strain developed by Hashizume at the

Chiba Serum Institute in 1975 (7). A summary of its characteristics,

prepared by Hirayama (9), indicates that in controlled studies, the strain

induces fewer local and febrile reactions than the standard Japanese strain

(Ikeda), Lister and EM-63 (Russian strain derived from the New York City

Board of Health strain). HI and neutralizing antibodies appear to be

equivalent. When the different strains were inoculated into the thalamus of

monkeys, the Japanese strain proved to be the least pathogenic. Some 50,000

Japanese children have been vaccinated with this strain; no serious adverse

reactions were detected. "

http://www.medscape.com/viewarticle/414504_2

" LC16m8, an attenuated VACV strain developed by Japan in 1975 for primary

vaccination, was derived by passing the Lister strain 36 times through

primary rabbit kidney cells at low temperature (30°C)[36]. The LC16m8

strain had a take rate of 95% (compared with 93.7% for Lister), fever rate

of 7.7% (compared with 26.6% for Lister), and lower neurovirulence in a

monkey assay. The lower fever rate and reduced neurovirulence were

considered indications that this was a safer vaccine[37]. Antibody titers

and induration size were lower than those of the Lister strain; however,

the effect of its decreased immunogenicity on the ability of this vaccine

to protect against smallpox infection is unknown since the vaccine was

never used in a smallpox-endemic region. "

--------------------------------------------------------

Sheri Nakken, R.N., MA, Classical Homeopath

Vaccination Information & Choice Network, Nevada City CA & Wales UK

$$ Donations to help in the work - accepted by Paypal account

vaccineinfo@... voicemail US 530-740-0561

(go to http://www.paypal.com) or by mail

Vaccines - http://www.nccn.net/~wwithin/vaccine.htm

Vaccine Dangers On-Line course - http://www.nccn.net/~wwithin/vaccineclass.htm

Homeopathy On-Line course - http://www.nccn.net/~wwithin/homeo.htm

ANY INFO OBTAINED HERE NOT TO BE CONSTRUED AS MEDICAL

OR LEGAL ADVICE. THE DECISION TO VACCINATE IS YOURS AND YOURS ALONE.

******

" Just look at us. Everything is backwards; everything is upside down.

Doctors destroy health, lawyers destroy justice, universities destroy

knowledge, governments destroy freedom, the major media destroy information

and religions destroy spirituality " .... Ellner

Our Anthrax information web site: http://www.dallasnw.quik.com/cyberella/

/files/VAERS.pdf

DESTROY QUARANTINED VACCINE:

http://www.PetitionOnline.com/mod_perl/signed.cgi?robi2662 & amp;amp;amp;amp;1

PETITION TO OVERTURN/REPEAL FERES DOCTRINE

http://www.petitiononline.com/fd1950/petition.html

To visit Dr. Meryl Nass's web site, go to: http://www.anthraxvaccine.org

Also visit: Anthrax Vaccine Benefit vs Risk: http://www.avip2001.net AND

http://www.MajorBates.com/

Anthrax Vaccine Network http://www.ngwrc.org/anthrax/default.asp

Military Vaccine Education Center link, http://www.milvacs.org

Sgt. Larson's story: http://www.ngwrc.org/anthrax/heroes/sandralarson.htm

http://www.avip2001.net/CongressionalTestimony.htm

Tom Heemstra's new book - http://www.anthraxadeadlyshotinthedark.com/index.html

Contact list owner: Gretchen at: anna_nim@...

[Guest guest]

Mark,

I just found this forum this evening, Although I recognize some

familiar names/usernames.. I located this forum by doing a

google search with this in the heading " Anthrax Vaccine and

Government "

Results 1 - 10 of about 181,000 for Anthrax Vaccine and Government

Yesterday I also found this site that may interest you?

Article writen by Bollyn from American Free Press

http://www.americanfreepress.net/Alternative_Health/U_S__Anthrax_Vacc

ine_Maker_Cal/u_s__anthrax_vaccine_maker_cal.html

I posted it up on this link for discussion to see if there was

anyone else out there with more information?

http://www.hspig.org/ipw-web/bulletin/bb/viewtopic.php?t=5804

It is also interesting to note that on the www.milvacs.org site and

the congressmen and representatives along with Defense Secretary

Rumsfield and Commander in Chief, W. Bush while at the

time running for Presidential Office in 2000 all made comments about

the Anthrax Vaccines but not one of these Officials today have put a

stop to them? and as of recent there has been more of a push from

the DOD to get them back in Action?? One good question that has

been on my mind and many other Ill veterans is why is it the middle

east is supposedly a high risk area for this Anthrax Virus (thus our

military members must be vaccinated prior to their deployment) but

our elected officials and higher White House Staff do not need to

fall under the same rule of thumb? Especially Rumsfield who

has made quite a few trips to the middle east and this is what he

had to say about this vaccine when asked...

http://www.milvacs.org/Quotes/

Taken from the link above:

Defense Secretary Rumsfeld, Pentagon News Briefings, October 25,

2001:

Q: Are you taking the anthrax vaccine, Mr. Secretary?

Secretary Rumsfeld: No.

Q: You're not being inoculated; you're not taking a series.

Secretary Rumsfeld: No. No.

Q: All right. No vaccine.

Secretary Rumsfeld: No, no, no.

Defense Secretary Rumsfeld, Pentagon News Briefings, October 28,

2001:

Q: Okay. Mr. Secretary, have you been vaccinated against anthrax?

Secretary Rumsfeld: No. Have you?

A good and current question to address to the Sec. of Defence would

be the same question with an additional twist to give him his own

policy back with " well isn't it DOD policy that any member of the

arm services heading into this potential high risk area be

vaccinated prior to?? " I would like to hear/read his response to

that!!!

Please do not view my post as meaning all elected officials... there

are some in Washington who are doing their best to do for the

American People and Service Members and grinding against the

grains...

nice to meet you btw and hello to all who know me!!!!

Hog

> Dr. Nass,

>

>

>

> Thanks for sending that link. I'm not sure if you remember me,

but we spoke

> about a month ago-I'm a reporter for the American Prospect

magazine in

> Washington working on a story about bioterror vaccine procurement.

I should

> let you know that I have filed a Freedom of Information Act

request on a

> handful of people involved in the military vaccine programs and am

trying to

> see (or uncover) their financial links to the pharmaceutical

industry.

>

>

>

> Also, I attended the Senate Subcommittee hearing last week and saw

your

> submitted testimony. I think you made a very persuasive argument

and I plan

> on quoting that in a forthcoming article on Bioshield II. Sadly, I

> misplaced your written testimony in the last week and wanted to

know if you

> might be able to send me a copy.

>

>

>

> Many thanks,

>

>

>

> Mark

>

>

>

> Mark Leon Goldberg

>

> Writing Fellow

>

> The American Prospect

>

> 2000 L Steet NW Suite 717

>

> Washington, DC 20036

>

> P: (202) 776-0730 EXT 120

>

> F: (202) 776 0740

>

> C: (202) 557 0795

>

>

>

> _____

>

> From: Meryl Nass [mailto:mnass@g...]

> Sent: Tuesday, February 15, 2005 9:45 AM

>

> Subject: Where is the money in bioterrorism?

>

>

>

> http://www.forbes.com/personalfinance/strategies/2005/02/14/

> cz_sg_0214soapbox_inl.html

>

>

> Meryl Nass, MD

> Mount Desert Island Hospital

> Bar Harbor, Maine 04609

> 207 288-5081 ext. 220

>

>

>

> Our Anthrax information web site:

http://www.dallasnw.quik.com/cyberella/

> /files/VAERS.pdf

> DESTROY QUARANTINED VACCINE:

> http://www.PetitionOnline.com/mod_perl/signed.cgi?robi2662

> <http://www.PetitionOnline.com/mod_perl/signed.cgi?

robi2662 & amp;amp;amp;1>

> & amp;amp;amp;amp;1

> PETITION TO OVERTURN/REPEAL FERES DOCTRINE

> http://www.petitiononline.com/fd1950/petition.html

> To visit Dr. Meryl Nass's web site, go to:

http://www.anthraxvaccine.org

> Also visit: Anthrax Vaccine Benefit vs Risk:

http://www.avip2001.net AND

> http://www.MajorBates.com/

> Anthrax Vaccine Network http://www.ngwrc.org/anthrax/default.asp

> Military Vaccine Education Center link, http://www.milvacs.org

> Sgt. Larson's story:

> http://www.ngwrc.org/anthrax/heroes/sandralarson.htm

> http://www.avip2001.net/CongressionalTestimony.htm

> Tom Heemstra's new book -

> http://www.anthraxadeadlyshotinthedark.com/index.html

> Contact list owner: Gretchen at: anna_nim@i...

>